A Company of Sysmex Group Hemostasis Product Catalogue · 1 Company Overview Innovation and Expertise in Hemostasis HYPHEN BioMed is a French company which is internationally recognized

HYPHEN BioMed155 rue d’Eragny 95000 Neuville sur Oise, France • Tel: +33 (0)1.34.40.65.10 • Web : www.hyphen-biomed.com

A Company of Sysmex Group

Hemostasis Product Catalogue

Experience the innovation!

Edition 2017

© Can Stock Photo / dolgachov

1 www.hyphen-biomed.com

Company Overview

Innovation and Expertise in Hemostasis

HYPHEN BioMed is a French company which is internationally recognized for its innovation and expertise in the �eld of Thrombosis, Hemostasis, and Auto-Immunity, both for diagnostic and research use. Since its foundation in 1999, continuous development of new technologies and new parameters,as recognized in the products such as HEMOCLOT™, BIOPHEN™ and ZYMUTEST™lines, the company has gained trust from hospital laboratories, research institutes as well as pharmaceutic companies all over the world.

Our experience and expertise allow us to o�er a leading product portfolio of high quality innovative tools for research and specialized in-vitro diagnostics. Today, with over 300 products, we continue our commitment to introduce new research and diagnostic tools to customers, aiming to be a reliable partner who provides a link (HYPHEN) between fundamental research and specialized applications to meet any customer or laboratory needs in the �eld.

Experience the innovation!

www.hyphen-biomed.com 2

Company Overview

More about Company

AsiaEurope

Oceania

North America

South America

Africa

Our products are available todayin almost all over the world throughthe extensive distributor network.Find your local representative at:www.hyphen-biomed.com

To know more about HYPHEN BioMed,visit our website: www.hyphen-biomed.comor contact us at:

Adress: 155 rue d’Eragny 95000 Neuville sur Oise, FranceTel: +33 (0)1 34 40 65 10Fax: +33 (0)1 34 48 72 36

Distribution Network

Contact us:

For Technical Support:e-mail: [email protected]

Other questions/general info:e-mail: [email protected]


Catalogue Overview

Please note that this catalogue contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. For more information, please contact our local representatives in your country. http://www.hyphen-biomed.com

Product Line Concept

BIOPHEN™ Innovative technology of chromogenic assays as well as calibrators and controls (traceable to international standards) for IVD but also research and pharmaceutical activity.

HEMOCLOT™ A range of clotting assays designed with highly puri�ed coagulation factors for IVD and research use as well as pharmaceutical activity.

ZYMUTEST™ Complete line of highly sensitive, accurate speci�c Enzyme Immunoassays (ELISA) which remains the reference method for the exploration of thrombotic diseases, �brinolysis, autoimmunity or drug induced complications such as HIT.

HYPHEN BioMed can also develop customized products. If you need a reagent, calibrators and controls for your project, please contact us - we may be able to help you.e-mail: [email protected], Tel: +33 (0)1 34 40 65 10

Customized Product

Definition

NEW: Products released recently and already available on the market.

On-demand: Products manufactured on demand. Please contact HYPHEN BioMed or your local representatives for minimum quantity and lead time.

Available soon: Products planned to be launched soon. Please contact HYPHEN BioMed for availability.

IVD: In-Vitro Diagnostic use.

CE: CE marked product for IVD use.

LRT: Liquid Reagent Technology. For ready-to-use reagents.

Abbreviation

DOAC: Direct Oral Anticoagulant

HIT: Heparin Induced Thrombocytopenia

vWD: von Willebrand Disease

RUO: For Research Use Only.

LIAPHEN™ A range of turbidimetric latex immunoassays for quantitative determination of di�erent molecules on citrated human plasma or puri�ed �uid.


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Table of Contents

Section 1. Global Assays ....................................................................................... 5

Section 2: Factor Assays........................................................................................ 7

Section 3: Anticoagulant Monitoring .........................................................11

Section 4: Thrombophilia...................................................................................15

Section 5. Platelet Function Assays ..............................................................19

Section 6. Hemophilia, vWD and other bleeding disorders .............21

Section 7. Fibrinolysis..........................................................................................23

Section 8. Calibrators & Controls ...................................................................25

Section 9. Auxiliary reagents ...........................................................................29

Section 10. Research ............................................................................................31

INDEX

by Catalogue Number.......................................................................................36

by Product Name ................................................................................................37


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Section 1:

Complete line of routine assays for hemostasis testing

Section 1: Global Assays


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Product Name Description Reference Presentation

THROMBOPHEN (5) CE-IVDReagent of Ca lcium Thromboplastin for the determination of prothrombin time (PT). CK555M 12 x 5 mL


CK511K 6 x 1 mL

CK512K 6 x 2.5 mL

CK515K 8 x 5 mL

CK515L 12 x 5 mL

CK521K 6 x 1 mL

CK522K 6 x 2.5 mL

Product Name Description Reference PresentationCK571K 6 x 1 mLCK572K 6 x 2 mLCK575K 8 x 5 mL

LIAPHEN™ Fibrinogen CE-IVDTurbidimetric latex immunoassay for the quantitativedetermination of Fibrinogen Antigen. 120102 4 x 5 mL

ZYMUTEST™ Fibrinogen RUOELISA Method for the quantitative determination ofFibrinogen Antigen. RK024A 96 tests


CK011K 6 x 2 mL

CK011L 6 x 8 mL

CK001K 6 x 2 mL

CK001L 6 x 8 mL

CE-IVD

HEMOCLOT™ Thrombin (human)

Reagent for the determination of Thrombin Time(purified thrombin mostly of α−form).

HEMOCLOT™ Thrombin Time (T.T.)

Reagent for clotting method for the determination ofthrombin time in human ci trated plasma .

RUO

CE-IVD

Prothrombin Time

Activated Partial Thromboplastin Time

Fibrinogen

Thrombin Time

FIBRIPHEN CE-IVDReagent for clotting method for fibrinogen, Claussquantitative Assay.

CEPHEN LS Liquid APTT Lupus sensitive

CE-IVDReagent for clotting method for the determination ofActivated Partial Thromboplastin Time, sens itive toci rculating Lupus Anticoagulant.

Reagent for clotting method for the determination of Activated Partial Thromboplastin Time .

CEPHEN Liquid APTT


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Section 1:Section 2: FactorAssays

Measurement of plasma factors and some of their activated forms involved in coagulation and thrombosis using clotting, chromogenic or immunological methods.

Assay Portfolio for Factors and other Hemostatic Proteins

Prothrombin

Factor V

Factor VII

Factor VIIa

Factor VII-X

Factor VIII:C

Factor IX

Factor IXa

Factor X

Factor XI

Factor XIa

Factor XII

Factor XIII

Immuno Depleted Plasma

(p. 8)

DP010A / DP010K

DP020A / DP020K

DP030A / DP030K

- -DP040A / DP040K

DP050A / DP050K

-DP060A / DP060K

DP070A / DP070K

-DP080A / DP080K

DP200A / DP200K

Clotting Method(p. 8 & 9)

- CK071K CK081KCK092K CK051K /

CK051L- - - - - - - -

Chromogenic(p. 8 & 9)

- - 221304 221312 -221402 / 221406

221802 / 221806

221812 221705 - 220412 - -

Specific Control Set(p. 26)

- - -224901

- - - 224601 - - 224801 - -

ELISA(p. 8 & 9)

- RK009A RK036A - - - RK032A - RK033A - - -RK034A

on-demand

* see section "Research" for other plasma deficient

New!

New!


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Section 1:Section 2: Factor Assays

Prothrombine

Facteur V

Facteur VII

Facteur VIIaFacteur VII-XFacteur VIII:C

Facteur IX

Facteur IXa

Facteur X

Facteur XI

Facteur XIa

Facteur XII

Facteur XIII

Immunodepleted Plasma for Clotting Assays


DP010A 1 x 1 mL

DP010K 6 x 1 mL

DP020A 1 x 1 mL

DP020K 6 x 1 mL

DP030A 1 x 1 mL

DP030K 6 x 1 mL

DP040A 1 x 1 mL

DP040K 6 x 1 mL

DP050A 1 x 1 mL

DP050K 6 x 1 mL

DP060A 1 x 1 mL

DP060K 6 x 1 mL

DP070A 1 x 1 mL

DP070K 6 x 1 mL

DP080A 1 x 1 mL

DP080K 6 x 1 mL

See on page 35 for deficient plasma for a research use only

Clotting, Chromogenic and Immunological Assays

Factor VProduct Name Description Reference Presentation

HEMOCLOT™ Factor V Reagent CE-IVDClotting method for quantitative determination of FV,requires a ca lcium Thromboplastin. CK071K 6 x 1 mL

ZYMUTEST™ Factor V RUO ELISA method for quantitative determination of FVantigen. RK009A 96 tests

Factor VIIProduct Name Description Reference Presentation

HEMOCLOT™ Factor VII Reagent CE-IVDClotting method for quantitative determination of FVII,requires a ca lcium Thromboplastin. CK081K 6 x 1 mL

BIOPHEN™ VII Chromogenic assay for quantitative determination ofFVII . 221304 R1, R3: 2 x 4 mL ; R2: 2 x 2 mL

R4: 4 x 25 mL

ZYMUTEST™ Factor VII RUOELISA method for quantitative determination of FVIIantigen. RK036A 96 tests

CK051K 6 x 1 mL

CK051L 20 x 1 mL

Factor VIIaProduct Name Description Reference Presentation

HEMOCLOT™ Factor VIIa CE-IVDClotting method for quantitative determination ofActivated FVII . CK092K R1, R2: 3 x 2 mL

BIOPHEN™ Factor VIIa RUOChromogenic assay for quantitative determination ofActivated FVII . 221312 R1, R3 : 2 x 4 mL; R2 : 2 x 2 mL;

R4 : 2 x 25 mL

HEMOCLOT™ VII-X CE-IVDClotting method for quantitative determination of FVIIand FX, requires a ca lcium Thromboplastin.

Factor IX Deficient Plasma CE-IVD Citrated human plasma deficient in Factor IX

Factor X Deficient Plasma CE-IVD Citrated human plasma deficient in Factor X

Factor XI Deficient Plasma CE-IVD Citrated human plasma deficient in Factor XI

Factor XII Deficient Plasma CE-IVD Citrated human plasma deficient in Factor XII

Factor VII Deficient Plasma CE-IVD Citrated human plasma deficient in Factor VII

Factor VIII:C Deficient Plasma CE-IVD Citrated human plasma deficient in Factor VIII

Clotting assays for the quantitative determination of factors activity in citrated human plasma, requires a calciumThromboplastin (FII, FV, FVII, FX) and cephaline / Calcium (FVIII, FIX, FXI, FXII) reagent.

Prothrombin Deficient Plasma CE-IVD Citrated human plasma deficient in Factor I I

Factor V Deficient Plasma CE-IVD Citrated human plasma deficient in Factor V

NEW

RUO


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Factor VIII:CProduct Name Description Reference Presentation

221402 R1, R2, R3: 2 x 2.5 mL; R4: 4 x 25 mL

221406 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

Factor IXProduct Name Description Reference Presentation

221802 R1, R2, R3: 2 x 2.5 mL; R4: 2 x 25 mL

221806 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

ZYMUTEST™ Factor IX RUO ELISA method for quantitative determination of FIXantigen. RK032A 96 tests

Factor IXaProduct Name Description Reference Presentation

BIOPHEN™ Factor IXa (ACT. FIX) RUO Chromogenic assay for quantitative determination ofActivated FIX. 221812 R1, R2, R3: 2 x 2.5 mL

R4: 2 x 25 mL ; Cal: 2 x 1 mL

Factor XProduct Name Description Reference Presentation

CK051K 6 x 1 mL

CK051L 20 x 1 mL

BIOPHEN™ Factor X RUO Chromogenic assay for quantitative determination of FX. 221705 R1, R2: 4 x 2.5 mL ;R3: 4 x 5 mL

ZYMUTEST™ Factor X RUO ELISA method for quantitative determination of FXantigen. RK033A 96 tests

Factor XIaProduct Name Description Reference Presentation

BIOPHEN™ Factor XIa RUO Chromogenic assay for quantitative determination ofActivated FXI . 220412 R1A, R1B, R2, R3: 2 x 3.0 mL

R4: 2 x 25 mL ; Cal: 2 x 2 mL

Factor XIIIProduct Name Description Reference Présentation

ZYMUTEST™ Factor XIII-A RUO ELISA method for quantitative determination of FXIII(sub-unit A).

RK034Aon-demand

96 tests

See on page 32 for hemostasis protein assay for a research use only

HEMOCLOT™ VII-X CE-IVDClotting method for quantitative determination of FVIIand FX, requires a ca lcium Thromboplastin.

BIOPHEN™ Factor IX CE-IVDChromogenic assay for quantitative determination ofFIX.

BIOPHEN™ FVIII:C CE-IVDChromogenic assay for quantitative determination ofFVIII:C.


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Activation, Regulation, Inhibition of Blood Coagulation


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Section 1:Section 3: Anticoagulant Monitoring

Complete range of reagents, calibrators and controls (HEMOCLOT™ and BIOPHEN™) for measurement of direct anticoagulants, heparins and their analogues for Diagnostic, Research and Pharmaceutical Industry use (methods adhere to recommendations of the European Pharmacopoeia).

Dedicated Calibrator and Controls

Assay Portfolio for Anticoagulant Treatments

LMWHUFH

Orgaran® and other

Sodium Danaparoïd

Arixtra® and other

Pentasaccharides

Rivaroxaban

Apixaban

Edoxaban

Dabigatran

Argatroban

Hirudin

IVD, CE

RUO

Chromogenic assay for direct anti-IIa.

Clotting assay for direct anti-IIa.

Chromogenic assay for direct anti-Xa.

Lyophilized chromogenic assay for anti-Xa.

Liquid chromogenic assay for anti-Xa.

Chromogenic anti-Xa assay by addition ofAntithrombin.

Chromogenic anti-IIa assay followingrecommendations of Pharmacopoeia.

Chromogenic anti-IIa assay

Chromogenic anti-Xa assay followingrecommendations of Pharmacopoeia.

◎

◎ ◎

BIOPHEN™ Anti-IIa (2 stages Heparin Assay)

BIOPHEN™ Heparin Anti-IIa (kinetics)

◎

BIOPHEN™ Anti-Xa (2 stages Heparin Assay)

◎ ◎

◎ ◎BIOPHEN™ Heparin (AT+) ◎ ◎

◎◎BIOPHEN™ DTI

◎ ◎ ◎HEMOCLOT™ Thrombin

Inhibitors

◎ ◎BIOPHEN™ DiXaI ◎

◎ ◎ ◎BIOPHEN™ Heparin ◎ ◎ ◎

◎ ◎ ◎ ◎ ◎BIOPHEN™ Heparin LRT ◎ ◎

◎

Heparins and their Analogues Direct Anti-Xa Direct Anti-IIa

Dedicated Calibrators and Controls


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HBPMHNF

Orgaran™ & autres

Danaparoïde Sodium

Arixtra™ & autres

Pentasaccharides

Rivaroxaban

Apixaban

Dabigatran

Argatroban

Hirudines

Reagents for Heparins and their AnaloguesProduct Name Description Reference Presentation

221011 R1, R2: 4 x 7.5 mL

221013 R1, R2: 3 x 3 mL

221015 R1, R2: 4 x 5 mL

221003 R1, R2: 3 x 3 mL

221006 R1, R2: 4 x 6 mL

BIOPHEN™ Heparin (AT+) RUOChromogenic assay for quantitative determination ofanti-Xa activi ty, us ing exogenous AT source . 221007 R1, R2: 2 x 7.5 mL

R3: 2 x 2.5 mL

BIOPHEN™ Anti-Xa (2 Stages Heparin Assay)

RUOTwo stages Anti-Xa chromogenic method for theHeparin activi ty measurement on plasma or purifiedmedium, according to Pharmacopeia .

221005 R1, R2, R3: 2 x 1 mL

BIOPHEN™ Anti-IIa(2 Stages Heparin Assay)

RUOTwo stages chromogenic method for the Heparin anti-I Ia activi ty measurement on plasma or purifiedmedium, according to Pharmacopeia .

220005 R1, R2, R3: 2 x 1 mL

BIOPHEN™ Heparin Anti-IIa (kinetics)

RUO Chromogenic Kinetic assay for quantitativedetermination of anti-I Ia activi ty for purified fluids . 221020 R1:2 x 5 mL

R2, R3: 2 x 10 mL ; R4: 2 x 20 mL

Calibrators and ControlsLow Molecular Weight Heparin (LMWH)


BIOPHEN™ Heparin Calibrator CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 222001 5 levels , 4 x 1 mL each

223001 C3, C4: 6 x 1 mL each

223801 C3: 12 x 1 mL

224201 C4: 12 x 1 mL

223701 CI, CII : 6 x 1 mL each

224301 CI : 12 x 1 mL

224401 CII : 12 x 1 mL

Unfractionated Heparin (UFH)


BIOPHEN™ UFH Calibrator CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 222301 5 levels , 4 x 1 mL each

223101 C1, C2: 6 x 1 mL each

224101 C1: 12 x 1 mL

223901 C2: 12 x 1 mL

Orgaran®


BIOPHEN™ Orgaran® Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 222201 5 levels , 4 x 1 mL each

BIOPHEN™ Orgaran® Control CE-IVD Refer to section 8. Calibrators and Controls (page 26). 223501 2 levels , 6 x 1 mL each

Arixtra®


BIOPHEN™ Arixtra® Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 222501 4 levels , 3 x 1 mL each

BIOPHEN™ Arixtra® Control CE-IVD Refer to section 8. Calibrators and Controls (page 26). 224001 2 levels , 6 x 1 mL each

Chromogenic assay for quantitative determination of anti-Xa activi ty. Lyophi l i zed reagent.

CE-IVDBIOPHEN™ Heparin

Chromogenic assay for quantitative determination of anti-Xa activi ty. Liquid reagent, ready to use.

CE-IVDBIOPHEN™ Heparin LRT

Human citrated plasma assayed for Fondaparinux (Arixtra™) using anti-Xa Heparin assay.

Refer to section 8. Calibrators and Controls (page 26).



Human citrated plasma assayed for LMWH using anti-Xa Heparin assay.

BIOPHEN™ LMWH Control

BIOPHEN™ UFH Control

Human citrated plasma assayed for Sodium Danaparoide (Orgaran™) using anti-Xa Heparin assay.

CE-IVD510(k)

CE-IVD510(k)

Human citrated plasma assayed for UFH using anti-Xa Heparin assay.

BIOPHEN™ LMWH Control Low CE-IVD510(k)

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Reagents for Direct Factor Xa Inhibitors (DiXaIs)Product Name Description Reference Presentation

221011 R1, R2: 4 x 7.5 mL

221013 R1, R2: 3 x 3 mL

221015 R1, R2: 4 x 5 mL

221003 R1, R2: 3 x 3 mL

221006 R1, R2: 4 x 6 mL

BIOPHEN™ DiXaI CE-IVDChromogenic assay for quantitative determinationof anti-Xa activi ty. Specific for DiXaIs . 221030 R1, R2: 3 x 2.5 mL

R3 : 4 x 25 mL

Calibrators and controls for Direct Factor Xa Inhibitors (DiXaIs)Rivaroxaban


BIOPHEN™ Rivaroxaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226001 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225101 2 levels , 6 x 1 mL each

BIOPHEN™ Rivaroxaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222701 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 224501 2 levels , 6 x 1 mL each

Apixaban


BIOPHEN™ Apixaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226101 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225201 2 levels , 6 x 1 mL each

BIOPHEN™ Apixaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226201 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225301 2 levels , 6 x 1 mL each

Edoxaban


BIOPHEN™ Edoxaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225501 2 levels , 6 x 1 mL each

Reagents for Direct Thrombin Inhibitors (DTIs)Product Name Description Reference Presentation

CK002K R1, R2: 3 x 1 mL

CK002L R1, R2: 3 x 2.5 mL

BIOPHEN™ DTI CE-IVDChromogenic assay for quantitative determinationof DTI activi ty. Specific to DTIs . 220202 R1, R2, R3: 2 x 2.5 mL

Calibrators and controls for Direct Thrombin Inhibitors (DTIs)Dabigatran


BIOPHEN™ Dabigatran Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222901 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225001 2 levels , 6 x 1 mL each

Dabigatran Plasma Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222801 3 levels , 4 x 1 mL each

Dabigatran Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 27). 224701 2 levels , 6 x 1 mL each

Human Plasma assayed for Edoxaban (Lixiana®, or Savaysa®) quantitative measurement using an anti-Xa method

Human citrated plasma assayed for Dabigatran (Pradaxa®) quantitative measurement using an anti-IIa method

HEMOCLOT™ Thrombin Inhibitors CE-IVDClotting assay for quantitative determination of DTIactivi ty.

Human Plasma assayed for Apixaban (Eliquis®) quantitative measurement using an anti-Xa method

Human Plasma assayed for Rivaroxaban (Xarelto®) quantitative measurement using an anti-Xa method

BIOPHEN™ Heparin CE-IVDChromogenic assay for quantitative determinationof anti-Xa activi ty. Lyophi l i zed reagent.

BIOPHEN™ Heparin LRT CE-IVDChromogenic assay for quantitative determination of anti-Xa activi ty. Liquid reagent, ready to use.

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BIOPHEN™ Edoxaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225401 2 levels , 6 x 1 mL each

BIOPHEN™ Edoxaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226401 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226501 3 levels , 4 x 1 mL each


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Calibrators and controls for Direct Thrombin Inhibitors (DTIs)

Argatroban


Argatroban Plasma Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC030K 5 levels , 4 x 1 mL each

Argatroban Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC035K 2 levels , 6 x 1 mL each

Hirudin


Plasma Hirudin Standard Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC020Kon-demand

2 levels , 3 x 1 mL each

Plasma Hirudin Standard High CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC020Lon-demand


Plasma Hirudin control CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC025Kon-demand


Reagents for the detection of Heparin Induced Thrombocytopenia (HIT)

ScreeningProduct Name Description Reference Presentation

ZYMUTEST™ HIA IgGAM CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgGAM. RK040D 96 tests

ZYMUTEST™ HIA MonoStrip, IgGAM CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgGAM, monostrip. RK041D 4 x 8 tests

IsotypingProduct Name Description Reference Presentation

ZYMUTEST™ HIA IgG CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgG. RK040A 96 tests

ZYMUTEST™ HIA mono strip, IgG CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgG, monostrip. RK041A 4 x 8 tests

ZYMUTEST™ HIA IgA CE-IVDELISA method for detection of heparin dependentantibody IgA.

RK040Con-demand

96 tests

ZYMUTEST™ HIA IgM CE-IVDELISA method for detection of heparin dependentantibody IgM.

RK040Bon-demand

96 tests

ZYMUTEST™ HIA IgG, IgA, IgM CE-IVDELISA method for detection of heparin dependentantibody IgG, IgA or IgM.

RK040Eon-demand

96 tests

Standardized ELISA method optimised for the detection of Heparin-dependent Antibodies in human plasma, serum or any biological fluid, allowing confirmation of HIT/HITT diagnosis or its clinical suspicion.

Human citrated plasma assayed for Argatroban (Arganova®) quantitative measurement using an anti-IIa method

Human citrated plasma assayed for Hirudin quantitative measurement using an anti-IIa method

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Section 1:Section 4: Thrombophilia

Measurement of plasma proteins controlling thrombosis andexhibiting antithrombotic properties (PC, PS, AT, etc...).

Regulation of blood coagulationthrough the Protein C/Protein S and AT pathways

ProcoagulantAntithrombotic

VIII

IXa VIIIa

X

PC

Thrombomodulin

Heparin

VIIaTF

VII

Plasmin

Plasminogen

IX

PS

TFPI

Prothrombin

V

Xa Va

Fibrinogen

Thrombin

Fibrin

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221123 R1, R2: 3 x 3 mL

221127 R1, R2: 4 x 7.5 mL

221102 R1, R2: 2 x 2.5 mL ; R3: 2 x 5 mL

221105 R1, R2: 4 x 5 mL; R3: 4 x 10 mL

BIOPHEN™ AT (Anti-IIa) CE-IVDChromogenic assay for quantitative determination ofAT by Anti-I Ia method. 221122 R1, R2: 2 x 2.5 mL

R3 : 2 x 25 mL

LIAPHEN™ AT CE-IVDTurbidimetric latex immunoassay for the quantitativedetermination of AT Antigen. 120002 R1: 2 x 2 mL, R2: 2 x 10 mL


HEMOCLOT™ Protein C CE-IVDClotting method for quantitative determination ofProtein C activi ty. CK031K R1, R2: 3 x 1 mL

BIOPHEN™ Protein C (LRT) CE-IVDChromogenic assay for quantitative determination ofProtein C activi ty. Liquid reagent, ready to use. 221211 R1 , R2 3 x 3 mL

BIOPHEN™ Protein C CE-IVD510(k)

Chromogenic assay for quantitative determination ofProtein C activi ty. Lyophi l i zed reagent. 221205 R1, R2: 4 x 5 mL

ZYMUTEST™ Protein C CE-IVDELISA method for quantitative determination ofProtein C Antigen. RK027A 96 tests


HEMOCLOT™ Protein S CE-IVDClotting method for quantitative determination ofProtein S activi ty. CK041K R1, R2: 3 x 1 mL

ZYMUTEST™ Total Protein S CE-IVDELISA method for quantitative determination of Tota lProtein S. RK021A 96 tests

ZYMUTEST™ Free Protein S CE-IVDELISA method for quantitative determination of FreeProtein S. RK015A 96 tests


HEMOCLOT™ Quanti V-L CE-IVD510(k)

Clotting method for quantitative determination ofactivated Protein C res is tance activi ty. CK065K R1: 3 x 2 mL; R2: 3 x 1 mL

BIOPHEN™ V-L CAL (undiluted) CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 222401 3 levels, 3 x 0.5 mL each

BIOPHEN™ Act. PC-r Control Plasma CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 223405 12 x 0.5 mL

BIOPHEN™ Normal Control Plasma CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 223201 12 x 1 mL


ZYMUTEST™ Protein Z RUO ELISA ki t for quantitative determination of Protein Z. RK031A 96 tests

Chromogenic assay for quantitative determination ofAT by Anti-Xa (human FXa ) method. Liquid reagent,ready to use.

BIOPHEN™ Antithrombin CE-IVD510(k)

Chromogenic assay for quantitative determination ofAT by Anti-Xa (bovine FXa ) method.

BIOPHEN™ AT anti-(h)-Xa LRT

Protein Z

Activated Protein C resistance

Protein S: Activity and Antigen

Protein C: Activity and Antigen

Antithrombin

CE-IVD


Sect

ion

4:

Thr

ombo

phili

a

Section 1:Section 4:Thrombophilia


HEMOCLOT™ LA-S CE-IVDDRVV reagent to screen for the presence of LupusAnticoagulants . CK090K 6 x 1 mL

HEMOCLOT™ LA-C CE-IVDDRVV reagent wi th high Phosphol ipid content toconfirm the presence of Lupus Anticoagulants . CK091K 6 x 1 mL

LA Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC081K C1, C2 : 6 x 0.5 mL each

LA Control Plasma Weak CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC082K C1 : 6 x 0.5 mL

LA Control Plasma High CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC083K C2 : 6 x 0.5 mL

BIOPHEN™ Normal Control PlasmaCE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 223201 12 x 1 mL

Product Name Description Reference PresentationZYMUTEST™ Anti- β2-Glycoprotein 1, IgG

CE-IVDELISA method for quantitative determination of Anti-β2-Glycoprotein 1, IgG - Isotype . RK014A 96 tests

ZYMUTEST™ Anti-β2-Glycoprotein 1, IgM

CE-IVDELISA method for quantitative determination of Anti-β2-Glycoprotein 1, IgM - Isotype . RK014B 96 tests

ZYMUTEST™ Anti- β2-Glycoprotein 1, IgA

RUOELISA method for quantitative determination of Anti-β2-Glycoprotein 1, IgA - Isotype .

RK014Con-demand

96 tests


ZYMUTEST™ ACA-APA, IgG CE-IVDELISA method for quantitative determination of Anti-cardiol ipin/Anti-Phosphol ipid IgG isotype .

RK029Aon-demand

96 tests

ZYMUTEST™ ACA-APA, IgM CE-IVDELISA method for quantitative determination of Anti-cardiol ipin/Anti-Phosphol ipid IgM isotype .

RK029Bon-demand

96 tests

ZYMUTEST™ ACA-APA, IgA RUOELISA method for quantitative determination of Anti-cardiol ipin/Anti-Phosphol ipid IgA i sotype .

RK029Con-demand

96 tests


ZYMUTEST™ Anti-Annexin V, IgG RUOELISA method, specific for quantitative determinationof Anti-Annexin V, IgG. RK005A 96 tests

ZYMUTEST™ Anti-Annexin V, IgM RUOELISA method, specific for quantitative determinationof Anti-Annexin V, IgM. RK005B 96 tests

ZYMUTEST™ Anti-Protein S, IgG RUOELISA method, specific for quantitative determinationof Anti-Protein S, IgG. RK020A 96 tests

ZYMUTEST™ Anti-Protein S, IgM RUOELISA method, specific for quantitative determinationof Anti-Protein S, IgM. RK020B 96 tests

ZYMUTEST™ Anti-Protein Z, IgG RUOELISA method, specific for quantitative determinationof Anti-Protein Z, IgG. RK025A 96 tests

ZYMUTEST™ Anti-Protein Z, IgM RUOELISA method, specific for quantitative determinationof Anti-Protein Z, IgM. RK025B 96 tests

ZYMUTEST™ Anti-Protein C, IgG RUOELISA method, specific for quantitative determinationof Anti-Protein C, IgG.

RK026Aon-demand

96 tests

ZYMUTEST™ Anti-Protein C, IgM RUOELISA method, specific for quantitative determinationof Anti-Protein C, IgM.

RK026Bon-demand

96 tests

ZYMUTEST™ Anti-Prothrombin IgG RUOELISA method, specific for quantitative determinationof Anti-Prothrombin, IgG.

RK007Aon-demand

96 tests

ZYMUTEST™ Anti-Prothrombin IgM RUOELISA method, specific for quantitative determinationof Anti-Prothrombin, IgM.

RK007Bon-demand

96 tests

Autoantibodies to Phospholipid Cofactor Proteins

Anti-Cardiolipin / Anti-Phospholipid Antibodies (ACA/APA)

Anti-β2GP1 Auto-antibodies

Lupus Anticoagulant

NEW

NEW

NEW

NEW

NEW


Sect

ion

5:

Plat

elet

Agg

rega

tion

Sect

ion

4:

Thr

ombo

phili

a



ZYMUTEST™ DDimer RUOELISA method for quantitative determination ofDDimers . RK023A 96 tests

ZYMUTEST™ FPA RUOCompetitive ELISA ki t for quantitative determinationof FPA in bentonite adsorbed human plasma . RK016A 96 tests

ZYMUTEST™ CRP RUO ELISA ki t for quantitative determination of CRP. RK010A 96 tests

ZYMUPHEN™ MP-ACTIVITY RUOChromogenic assay for mi croparticles 's procoagulant activi ty in human plasma 521096 2 x 48 tests

ZYMUPHEN™ MP-TF RUOChromogenic assay for quantitative determination ofexposed Ti s sue Factor mi croparticles 's procoagulantactivi ty (MP-TF)

521196 2 x 48 tests

ZYMUTEST™ Tissue Factor (full length)

RUOEnhanced ELISA ki t for quantitative determination ofTi s sue Factor (FL-TF global 1-263) RK035A 96 tests

ZYMUTEST™ Total Tissue Factor RUOEnhanced ELISA ki t for quantitative determination ofTi s sue Factor (Global 1-263 and extracel lular 1-219only).

RK042A 96 tests

Pathological markers

Sect

ion

5:

Plat

elet

Agg

rega

tion

Ass

ays

Section 1:Section 5: Platelet Function Assays


Extended range of reagent line for Platelet functional assays including reagents for Platelet Aggregation.

Sect

ion

5:

Plat

elet

Fun

ctio

nA

ssay

s

Section 1:Section 5: Platelet Functional Assays

Sysmex CS-5100 Sysmex CS-2100i Sysmex CS-2500


Platelet aggregation reagentsProduct Name Description Reference Presentation

ADP CE-IVD ADP (200 µM) AG001K 3 x 0.5 mL

Epinephrine CE-IVD Epinephrine (1 mM) AG002K 3 x 0.5 mL

Arachidonic acid CE-IVD Arachidonic Acid (sodiumsa l t- 5 mg/mL (15 mM)) AG003K 3 x 0.5 mL

Ristocetin CE-IVD Ristocetin (7.5 mg per via l ) AG004K 3 x 0.5 mL

Collagen CE-IVD Col lagen (1 mg/mL) AG005K Reagent: 3 x 0.5 mL;Diluent: 3 x 12 mL

AG006A 1 x 5 mL

AG006K 3 x 5 mL

Note: Applications are available on Sysmex CS-series (CS-2000i/CS-2100i, CS-2400/2500, CS-5100)

Platelets for determination of vWF through Ris tocetin Co-Factor Lyophilized platelets CE-IVD

* Example of the results

Platelet activation markerProduct Name Description Reference Presentation

ZYMUTEST™ PF4 RUO ELISA ki t for quantitative determination of PF4. RK006A 96 tests

Plasma PF4 control RUO Qual i ty control plasma for PF4 SC013K 2 levels , 3 x 0.5 mL each


Sect

ion

6:

Ble

edin

g D

isor

ders

Section 1:

Complete line of diagnostic assays for Hemophilia and Other Bleeding Disorders

Section 6: Hemophilia, von Willebrand Disease

and Other Bleeding Disorders


Sect

ion

6:

Ble

edin

g D

isor

ders

NEW

Section 1:Section 6:

Hemophilia, von Willebrand Diseaseand Other Bleeding Disorders

NEW

NEW

NEW

NEW

Hemophilia AProduct Name Description Reference Presentation

221402 R1, R2, R3: 2 x 2.5 mL; R4: 4 x 25 mL

221406 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

DP040A 1 x 1 mL

DP040K 6 x 1 mL

Auto and Allo-antibodies Anti-Factor VIIIProduct Name Description Reference Presentation

ZYMUTEST™ Anti FVIII IgG Mono Strip

CE-IVDELISA method for quantitative determination of Anti-FVIII IgG. RK039A 32 tests

Hemophilia BProduct Name Description Reference Presentation

221802 R1, R2, R3: 2 x 2.5 mL; R4: 2 x 25 mL

221806 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

DP050A 1 x 1 mL

DP050K 6 x 1 mL

ZYMUTEST™ Factor IX RUOELISA method for Factor IX antigen in ci trated humanplasma or other biologica l fluids . RK032A 96 tests

Product Name Description Reference Présentation

LIAPHEN™ vWF:Ag CE-IVD

Immunoturbidimetric assay for in vi tro quantitativedetermination of von Wi l lebrand Factor Antigen (vWF:Ag) on human ci trated plasma . Liquid reagent, ready touse.

120206 R1: 4 x 5 mL; R2: 4 x 6 mL

ZYMUTEST™ vWF CE-IVDELISA method for quantitative determination of vonWi l lebrand Factor (vWF) Antigen. RK030A 96 tests

ZYMUTEST™ vWF:CBA CE-IVDELISA method for quantitative determination ofcol lagen binding activi ty (CBA) of von Wi l lebrandFactor.

RK038A 96 tests

Ristocetin CE-IVD Ristocetin (7.5 mg per via l ) AG004K 3 x 0.5 mL

AG006A 1 x 5 mL

AG006K 3 x 5 mL


HEMOCLOT™ Factor VIIa CE-IVDClotting method for quantitative determination ofActivated FVII . CK092K R1, R2: 3 x 2 mL

BIOPHEN™ Factor VIIa RUOChromogenic assay for quantitative determination ofActivated FVII . 221312 R1, R3 : 2 x 4mL; R2 : 2 x 2mL;

R4 : 2 x 25mL

BIOPHEN™ FVIIa Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 226301 6 x 2 mL

BIOPHEN™ FVIIa control set CE-IVD Refer to section 8. Calibrators and Controls (page 26). 224901 C1, C2 : 3 x 1 mL


BIOPHEN™ Factor IXa (ACT. FIX) RUO Chromogenic assay for quantitative determination ofActivated FIX. 221812 R1, R2, R3: 2 x 2.5 mL

R4: 2 x 25 mL ; Cal: 2 x 1 mL

BIOPHEN™ Factor XIa RUO Chromogenic assay for quantitative determination ofActivated FXI . 220412 R1A, R1B, R2, R3: 2 x 3.0 mL

R4: 2 x 25 mL ; Cal: 2 x 2 mL

BIOPHEN™ FIXa Control set RUO Refer to section 8. Calibrators and Controls (page 26). 224601 C1: 6 x 1 mL C2: 6 x 1 mL

BIOPHEN™ FXIa Control set RUO Refer to section 8. Calibrators and Controls (page 26). 224801 C1: 3 x 1 mL C2: 3 x 1 mL

Others activated factors

Monitoring of by-passing agents

von Willebrand Desease

BIOPHEN™ Factor IX CE-IVDChromogenic assay for quantitative determination ofFIX in human plasma or therapeutic concentrate .

Lyophilized platelets CE-IVDPlatelets for determination of vWF activi ty throughRistocetin Co-Factor assay.

Hemophilia

BIOPHEN™ FVIII:C CE-IVDChromogenic assay for quantitative determination of FVIII:C in human plasma or therapeutic concentrate.

Immunodepleted plasma deficient in FVIII .

Factor IX Deficient Plasma CE-IVD Immunodepleted plasma deficient in Factor IX

Factor VIII:C Deficient Plasma CE-IVD

NEW


Sect

ion

7:

Fibr

inol

ysis

n

Complete range of reagents, calibrators and controls for Fibrinolysis exploring

Pro-�brinolytic

Anti-�brinolytic

Fibrinolysis Mechanisms

Section 1: Section 7: Fibrinolysis


Sect

ion

7:

Fibr

inol

ysis

n

Section 1:Section 7: Fibrinolysis

Plasminogen and α2-antiplasmin


BIOPHEN™ Plasminogen (LRT) CE-IVDChromogenic assay for quantitative determination ofPlasminogen activi ty. Liquid reagent, ready to use. 221511 R1, R2: 3 x 3 mL

BIOPHEN™ α2-Antiplasmin (LRT) CE-IVDChromogenic assay for quantitative determination ofα2-antiplasmin. Liquid reagent, ready to use. 220502 R1, R2: 3 x 3 mL

PAI-1 and tPA: Activity and Antigen


ZYMUTEST™ PAI-1 Activity RUOELISA method for quantitative determination of PAI-1activi ty. RK019A 96 tests

ZYMUTEST™ PAI-1 Antigen CE-IVDELISA method for quantitative determination of PAI-1antigen. RK012A 96 tests

ZYMUPHEN™ tPA activity RUOImmunoenzymatic assay for quantitativedetermination of tPA activi ty.

521296on-demand

96 tests

ZYMUTEST™ tPA Antigen CE-IVDELISA method for quantitative determination of tPAantigen. RK011A 96 tests

TAFI, uPA & complexes


ZYMUTEST™ (Total) TAFI:Ag RUOELISA method for quantitative determination ofhuman Tota l TAFI Antigen. RK008A 96 tests

ZYMUTEST™ (Activatable) TAFI RUOELISA method for quantitative determination ofhuman TAFI activi table forms . RK037A 96 tests

ZYMUTEST™ uPA Antigen RUOELISA method for quantitative determination of uPAantigen.

RK013Aon-demand

96 tests

ZYMUTEST™ tPA-PAI-1 complexes

RUOELISA method for quantitative determination of tPA-PAI-1 complexes .

RK017Aon-demand

96 tests

ZYMUTEST™ uPA-PAI-1 complexes

RUOELISA method for quantitative determination of uPA-PAI-1 complexes .

RK018Aon-demand

96 tests

Controls for reagents for Fibrinolysis Assays.


Plasma PAI-1 control RUO Refer to section 8. Calibrators and Controls (page 28). SC011K 2 levels , 3 x 1 mL each

Plasma U.T.A. control (uPA/tPA/Annexin V)

RUO Refer to section 8. Calibrators and Controls (page 28). SC017K 2 levels , 3 x 1 mL each

25

Sect

ion

8:

Cal

ibra

tors

&

Con

trol

s

Section 1:Section 8: Calibrators and Controls

Complete line of calibrators and controls, standardized against WHO International Standards (when available), for the measurement of the various proteins involved in regulation of blood hemostasis and thrombosis as well as for anticoagulant drugs.


Sect

ion

8:

Cal

ibra

tors

&

Con

trol

s


NEW

NEW


BIOPHEN™ Plasma Calibrator CE-IVD510(k)

Normal Human Plasma for the cal ibration of somecoagulation factors . 222101 12 x 1 mL

BIOPHEN™ Normal Control Plasma CE-IVD510(k)

Normal Control Plasma for coagulation assay qual i tycontrol . 223201 12 x 1 mL

BIOPHEN™ Abnormal Control Plasma CE-IVD510(k)

Abnormal Control Plasma for coagulation assay qual i tycontrol . 223301 12 x 1 mL

EASYPLASMA™ Calibrator CE-IVDRoutine cal ibrator plasmas wi th l imi ted numbers ofparameters . 226601 6 x 1 mL

EASYPLASMA™ Control Set CE-IVDRoutine control plasmas wi th l imi ted numbers ofparameters . 225601 C1, C2: 6 x 1 mL each


BIOPHEN™ FVIIa Calibrator CE-IVD Cal ibrator for Factor VIIa assays . 226301 6 x 2 mL

BIOPHEN™ FVIIa control set CE-IVD Factor VIIa qual i ty control set. 224901 C1, C2 : 3 x 1 mL each

BIOPHEN™ FIXa Control set RUO Factor IXa qual i ty control set. 224601 C1, C2: 6 x 1 mL each

BIOPHEN™ FXIa Control set RUO Factor XIa qual i ty control set. 224801 C1, C2: 3 x 1 mL each

Low Molecular Weight Heparin (LMWH)Product Name Description Reference Presentation

BIOPHEN™ Heparin Calibrator CE-IVD510(k)

LMWH ca l ibrator plasma set. 222001 5 levels , 4 x 1 mL each

223001 C3, C4: 6 x 1 mL each

223801 C3: 12 x 1 mL

224201 C4: 12 x 1 mL

223701 CI, CII : 6 x 1 mL each

224301 CI : 12 x 1 mL

224401 CII : 12 x 1 mL

Unfractionated Heparin (UFH)Product Name Description Reference Presentation

BIOPHEN™ UFH Calibrator CE-IVD510(k)

UFH ca l ibrator plasma set. 222301 5 levels , 4 x 1 mL each

223101 C1, C2: 6 x 1 mL each

224101 C1: 12 x 1 mL

223901 C2: 12 x 1 mL

Orgaran®Product Name Description Reference Presentation

BIOPHEN™ Orgaran® Calibrator CE-IVD Orgaran® ca l ibrator plasma set. 222201 5 levels , 4 x 1 mL each

BIOPHEN™ Orgaran® Control CE-IVD Orgaran® qual i ty control plasma set. 223501 2 levels , 6 x 1 mL each

Arixtra®Product Name Description Reference Presentation

BIOPHEN™ Arixtra® Calibrator CE-IVD Arixtra® ca l ibrator plasma set. 222501 4 levels , 3 x 1 mL each

BIOPHEN™ Arixtra® Control CE-IVD Arixtra® qual i ty control plasma set. 224001 2 levels , 6 x 1 mL each

CE-IVD510(k)

UFH qual i ty control plasma set. BIOPHEN™ UFH Control

Multi-Calibrators and Controls

Activated Factor Specific Calibrator and Controls

Heparins and their Analogues

LMWH qual i ty control plasma set.

LMWH qual i ty control plasma set, low range .CE-IVD510(k)BIOPHEN™ LMWH Control Low

CE-IVD510(k)BIOPHEN™ LMWH Control

NEW

NEW


Sect

ion

8:

Cal

ibra

tors

&

Con

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s


RivaroxabanProduct Name Description Reference Presentation

BIOPHEN™ Rivaroxaban Calibrator Low CE-IVD Rivaroxaban ca l ibrator plasma set, low range . 226001 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control Low CE-IVD Rivaroxaban qual i ty control plasma set, low range . 225101 2 levels , 6 x 1 mL each

BIOPHEN™ Rivaroxaban Calibrator CE-IVD Rivaroxaban ca l ibrator plasma set, s tandard range . 222701 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control CE-IVD Rivaroxaban qual i ty control plasma set, s tandard range . 224501 2 levels , 6 x 1 mL each

ApixabanProduct Name Description Reference Presentation

BIOPHEN™ Apixaban Calibrator Low CE-IVD Api xaban ca l ibrator plasma set, low range . 226101 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control Low CE-IVD Api xaban qual i ty control plasma set, low range . 225201 2 levels , 6 x 1 mL each

BIOPHEN™ Apixaban Calibrator CE-IVD Api xaban ca l ibrator plasma set, s tandard range . 226201 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control CE-IVD Api xaban qual i ty control plasma set, s tandard range . 225301 2 levels , 6 x 1 mL each

EdoxabanProduct Name Description Reference Presentation

BIOPHEN™ Edoxaban Control Low CE-IVD Edoxaban qual i ty control plasma set, low range . 225401 2 levels , 6 x 1 mL each

BIOPHEN™ Edoxaban Control CE-IVD Edoxaban qual i ty control plasma set, s tandard range . 225501 2 levels , 6 x 1 mL each

DabigatranProduct Name Description Reference Presentation

BIOPHEN™ Dabigatran Calibrator Low CE-IVD Dabigatran ca l ibrator plasma set, low range . 222901 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Low CE-IVD Dabigatran qual i ty control plasma set, low range . 225001 2 levels , 6 x 1 mL each

Dabigatran Calibrator CE-IVD Dabigatran ca l ibrator plasma set, s tandard range . 222801 3 levels , 4 x 1 mL each

Dabigatran Control CE-IVD Dabigatran qual i ty control plasma set, s tandard range . 224701 2 levels , 6 x 1 mL each

ArgatrobanProduct Name Description Reference Presentation

Argatroban Plasma Calibrator CE-IVD Argatroban ca l ibrator plasma set. SC030K 5 levels , 4 x 1 mL each

Argatroban Control Plasma CE-IVD Argatroban qual i ty control plasma set. SC035K 2 levels , 6 x 1 mL each

HirudinProduct Name Description Reference Presentation

Plasma Hirudin Standard Low CE-IVD Hirudin ca l ibrator plasma set, low range . SC020Kon-demand


Plasma Hirudin Standard High CE-IVD Hirudin ca l ibrator plasma set, high range . SC020Lon-demand


Plasma Hirudin control CE-IVD Hirudin qual i ty control plasma set. SC025Kon-demand


Direct Anti-Xa Inhibitors

Direct Thrombin Inhibitors

NEW

NEW

NEW

NEW

BIOPHEN™ Edoxaban Calibrator Low CE-IVD Edoxaban ca l ibrator plasma set, low range . 226401 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Calibrator CE-IVD Edoxaban ca l ibrator plasma set, s tandard range . 226501 3 levels , 4 x 1 mL each


Sect

ion

8:

Cal

ibra

tors

&

Con

trol

s



BIOPHEN™ V-L CAL (undiluted) CE-IVD aPC res is tance ca l ibration plasma set 222401 3 levels , 3 x 0.5 mL each

BIOPHEN™ Act. PC-r Control Plasma CE-IVD aPC abnormal qual i ty control set. 223405 12 x 0.5 mL


Plasma Protein S control RUOProtein S (free and tota l ) qual i ty control plasma set forELISA method. SC050K 2 levels , 3 x 0.5 mL each


High Positive DDimer Control Plasma RUO Pathologica l concentration (about 2 μg/mL). SC101K 6 x 1 mL

Negative DDimer Control Plasma RUO Concentration less than 0.40 µg/mL. SC102K 6 x 1 mL

DDimer Control Plasma Low RUO Pathologica l concentration (about 0.6 μg/mL). SC103K 6 x 1 mL


LA Control Plasma CE-IVDSet of lyophi l i zed qual i ty control plasmas , weak andhigh pos itive, for use in Lupus Anticoagulant clottingassays .

SC081K C1, C2: 6 x 0.5 mL each

LA Control Plasma Weak CE-IVDSet of lyophi l i zed qual i ty control plasmas , weakpos itive, for use in Lupus Anticoagulant in vi tro clotting assays .

SC082K C1: 6 x 0.5 mL

LA Control Plasma High CE-IVDSet of lyophi l i zed qual i ty control plasmas , highpos itive, for use in Lupus Anticoagulant in vi tro clotting assays .

SC083K C2: 6 x 0.5 mL


FPA control RUO Qual i ty control plasma set for FPA SC015K 2 levels , 3 x 1 mL each

Plasma PAI-1 control RUO Qual i ty control plasma set for PAI-1 SC011K 2 levels , 3 x 1 mL each

Plasma U.T.A. control RUO Qual i ty control plasma set for Annexin V, tPA and uPA SC017K 2 levels , 3 x 1 mL each

Activated Protein C resistance

Protein S

D-Dimers

Lupus Anticoagulant

Fibrinolysis

NEW

NEW

NEW


Sect

ion

9:

Buf

fers

& o

ther

au

xilia

ry r

eage

nts

Section 1:

Complete line of bu�ers and other auxiliary reagents for hemostasis assays

Section 9: Auxiliary Reagents


Sect

ion

9:

Buf

fers

& o

ther

au

xilia

ry r

eage

nts

Section 1:Section 9: Auxiliary Reagents

Description

Description

Description

NEW

NEW

NEW

NEW

Buffers & Solutions for Clotting or Chromogenic AssaysProduct Name Description Reference Presentation

AR021A 1 x 25 mLAR021K 3 x 25 mLAR021L 12 x 25 mLAR001A 3 x 25 mLAR001K 12 x 25 mLAR002A 1 x 25 mLAR002K 3 x 25 mLAR026A 3 x 25 mLAR026K 12 x 25 mLAR004A 1 x 50 mLAR004K 3 x 50 mL

Tris-NaCl buffer, pH 7.40 (TBS) RUOBuffers and solutions for clotting & chromogenic assays . AR028K 4 x 20 mL

AR005A 1 x 50 mLAR005K 3 x 50 mLAR005L 4 x 20 mLAR006A 1 x 50 mLAR006K 3 x 50 mLAR007A 1 x 50 mLAR007K 3 x 50 mLAR008A 1 x 50 mLAR008K 3 x 50 mLAR009A 1 x 50 mLAR009K 3 x 50 mL

Tris NaCl EDTA PEG buffer, 10 x conc. pH 8.4 RUO Buffers for chromogenic assays . AR015A 1 x 10 mL

Tris NaCl EDTA PEG buffer, pH 8.40 RUO Buffers for chromogenic assays . AR030K 4 x 20 mL

Tris EDTA NaCl, pH 8.40 RUO Buffers for chromogenic assays . AR029K 4 x 20 mL

Tris EDTA buffer, 10 x conc. pH 8.40 RUO Buffers for chromogenic assays . AR015B 1 x 20 mL

Tris-BSA buffer, 10x conc. pH 7.30 RUO Buffers for chromogenic assays . AR020A 1 x 20 mL

Prothrombin Activator Diluent RUO Buffers for chromogenic assays . AR022A 1 x 20 mL

AT-Tris buffer Anti-Xa RUOBuffers for chromogenic assays . (Progress ive Antithrombin) AR103A 1 x 10 mL

AT-Tris buffer Anti-IIa RUOBuffers for chromogenic assays . (Progress ive Antithrombin) AR104A 1 x 10 mL

Buffers and Solutions for ELISA Product Name Description Reference Presentation

Dilution buffer RUO Di lution buffer wi th a lbumin for ELISA. AR010A 1 x 50 mL

FPA anticoagulant solution RUO Anticoagulant solution specific for the FPA Assay. AR013A 1 x 20 mL

AR011A 1 x 50 mLAR011K 3 x 50 mL

Fibrinolysis Sample Diluent RUO Di luent for Fibrinol ys i s investigation by ELISA. AR016A 1 x 50 mL

ELISA Conjugate Diluent bufferwith albumin. For ELISA

RUO Conjugate Di luent for ELISA. AR017A 1 x 25 mL

Autoimmunity Sample Diluent RUO Sample Di luent for ELISA. AR018A 1 x 50 mL

Stop solution RUO Stop solution for ELISA. AR019A 1 x 6 mL

B2F Sample Diluent (B2GP1/Fibrinogen/Fibronectin)

RUOSample Di luent for ELISA (B2GP1/Fibrinogen/Fibronectin). AR023A 1 x 60 mL

Bentonite suspension RUO Buffers and Solutions for ELISA. AR024A 1 x 50 mL

Other SolutionsProduct Name Description Reference Presentation

223602 10 x 2 mL223605 8 x 5 mL

Tetramethylbenzidine (TMB) substrate RUO ELISA substrates AR012A 1 x 25 mL

High Sensitivity Tetramenthybenzidine substrate (TMB-HS)

RUO ELISA substrates AR027A 1 x 25 mL

Para-Nitro-Aniline (pNA) RUOStandard solution for control l ing photometers at 405 nm (Reference Material). AR014A 1 x 5 mL

Wash solutionfor microparticle kits

RUOWash Solution for mi croparticle ki t, Zymuphen ™ MP-Activi ty (ref. 521096). AR025A 1 x 50 mL

Imidazole buffer CE-IVD

Calcium chloride 0.025M (M/40) CE-IVD

Calcium chloride 0.25M (M/4) CE-IVD

Pool of normal human Plasma .

Wash solution for ELISA.

Buffers and solutions for clotting assays .

Buffers for chromogenic assays .

Buffers for chromogenic assays .

Buffers for chromogenic assays .(For BIOPHEN® VIII :C, FIX, FIXa )

BIOPHEN™ Normalplasma CE-IVD

Buffers and solutions for clotting & chromogenic assays .

Special Tris-BSA buffer CE-IVD

Wash solution RUO

Tris-NaCl buffer, pH 8.4 (I = 0.3) RUO

Tris-NaCl buffer, with Albumin - pH 7.40

Buffers and solutions for clotting assays .

Tris buffer, pH 8.4 RUO

Phosphate NaCl (PBS) buffer, pH 7.5 RUO

Phosphate NaCl (PBSA) buffer, pH 7.5 RUO

Tris-NaCl buffer, pH 7.50 (TBS) RUO

Auxiliary Reagents

Calcium Chrol ide solutions for clotting assays .

Di lution buffers for clotting assays .

Ca lcium Chrol ide solutions for clotting assays . 10 fold concentrated.

RUOBuffers and solutions for clotting & chromogenic assays .


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Section 1:Section 10: Research

Research reagents available in kits or as a component (Proteins, enzymes, substrates, etc ) to meet your needs.


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Purified ProteinsPurified Human Proteins and EnzymesProduct Name Nature Reference Presentation

EZ004Bon-demand

1 x 10 µg

EZ004C 1 x 100 µg

PP004A 1 x 150 µg

PP004K 6 x 150 µg

PP004B 1 x 1.5 mg

PP004L 10 x 1.5 mg

PP004D 1 x 3.75 mg

PP004M 10 x 3.75 mg

PP004C 1 x 10 mg

β2-Glyco-Protein I (β2GPI) RUO Human PP010A 1 x 100 µg

C4b-Binding Protein RUO Human PP015A 1 x 100 µg

Factor VII RUO Human PP013A 1 x 100 µg

Factor IX RUO Human PP007A 1 x 100 µg

Factor IXa RUO Human EZ010B 1 x 100 IU

Factor X RUO Human PP008A 1 x 100 µg

EZ007A 1 x 10 µg

EZ007K 6 x 10 µg

EZ007B 1 x 0.1 mg

EZ007C 1 x 0.5 mg

Factor XIIa RUO Human EZ012Aon-demand

1 x 100 ng

PP001A 1 x 5 mg

PP001K 6 x 5 mg

PP001B 1 x 100 mg

PP001C 1 x 1 g

Fibrinogen, salt free RUO Human PP001R 1 x 100 mg

PP002A 1 x 5 mg

PP002K 6 x 5 mg

PP002B 1 x 100 mg

PP002C 1 x 1 g

Fibrinogen Fragment D RUO Human PP016A 1 x 200 µg

Fibrinogen Fragment E RUO Human PP018A 1 x 200 µg

Fibrinogen Fragment E3t RUO Human PP019A 1 x 200 µg

Fibrin Fragment DD RUO Human PP017A 1 x 200 µg

Fibrin Fragment E (FFE) RUO Human PP020A 1 x 200 µg

Heparin cofactor II RUO Human PP014C 1 x 1 mg

EZ014A 1 x 2.5 IU

EZ014Bon-demand

1 x 25 IU

PP005A 1 x 200 µg

PP005B 1 x 1.5 mg

PP005C 1 x 5 mg

Platelet Factor 4 (PF4) RUO Human PP003A 1 x 100 µg

PP501B 1 x 2 mL

PP501K 6 x 2 mL

Protein C RUO Human PP009A 1 x 100 µg

Protein S RUO Human PP012A 1 x 100 µg

Protein Z RUO Human PP011A 1 x 100 µg

RUOPlasmin

Prekallikrein Pool RUO

Fibrinogen RUO

Fibrinogen, plasminogen free RUO

Human

Human

Human

Plasminogen RUO

Anti-Thrombin (AT) RUO

Activated Protein C RUO

Factor Xa RUO

Human

Human

Human

Human

Human

Purified ProteinsPurified Human Proteins and EnzymesProduct Name Nature Reference Presentation

EZ004Bon-demand

1 x 10 µg

EZ004C 1 x 100 µg

PP004A 1 x 150 µg

PP004K 6 x 150 µg

PP004B 1 x 1.5 mg

PP004L 10 x 1.5 mg

PP004D 1 x 3.75 mg

PP004M 10 x 3.75 mg

PP004C 1 x 10 mg

β2-Glyco-Protein I (β2GPI) RUO Human PP010A 1 x 100 µg

C4b-Binding Protein RUO Human PP015A 1 x 100 µg

Factor VII RUO Human PP013A 1 x 100 µg

Factor IX RUO Human PP007A 1 x 100 µg

Factor IXa RUO Human EZ010B 1 x 100 IU

Factor X RUO Human PP008A 1 x 100 µg

EZ007A 1 x 10 µg

EZ007K 6 x 10 µg

EZ007B 1 x 0.1 mg

EZ007C 1 x 0.5 mg

Factor XIIa RUO Human EZ012Aon-demand

1 x 100 ng

PP001A 1 x 5 mg

PP001K 6 x 5 mg

PP001B 1 x 100 mg

PP001C 1 x 1 g

Fibrinogen, salt free RUO Human PP001R 1 x 100 mg

PP002A 1 x 5 mg

PP002K 6 x 5 mg

PP002B 1 x 100 mg

PP002C 1 x 1 g

Fibrinogen Fragment D RUO Human PP016A 1 x 200 µg

Fibrinogen Fragment E RUO Human PP018A 1 x 200 µg

Fibrinogen Fragment E3t RUO Human PP019A 1 x 200 µg

Fibrin Fragment DD RUO Human PP017A 1 x 200 µg

Fibrin Fragment E (FFE) RUO Human PP020A 1 x 200 µg

Heparin cofactor II RUO Human PP014C 1 x 1 mg

EZ014A 1 x 2.5 IU

EZ014Bon-demand

1 x 25 IU

PP005A 1 x 200 µg

PP005B 1 x 1.5 mg

PP005C 1 x 5 mg

Platelet Factor 4 (PF4) RUO Human PP003A 1 x 100 µg

PP501B 1 x 2 mL

PP501K 6 x 2 mL

Protein C RUO Human PP009A 1 x 100 µg

Protein S RUO Human PP012A 1 x 100 µg

Protein Z RUO Human PP011A 1 x 100 µg

Activated Protein C RUO

Factor Xa RUO

Plasminogen RUO

Anti-Thrombin (AT) RUO

Fibrinogen RUO

Fibrinogen, plasminogen free RUO

Human

Human

RUOPlasmin

Prekallikrein Pool RUO

Human

Human

Human

Human

Human

Human


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Purified Proteins (Continued)Purified Human Proteins and Enzymes (Continued)Product Name Nature Reference Presentation

PP006B 1 x 1 mg

PP006K 6 x 1 mg

EZ006O 1 x 10 NIH*

EZ006K 6 x 10 NIH*

EZ006A 1 x 100 NIH*

EZ006L 10 x 100 NIH*

EZ006B 1 x 1000 NIH*

PP021B 1 x 1 mg

PP021K 6 x 1 mg

EZ005Aon-demand

1 x 1,000 uni ts

EZ005Bon-demand

1 x 10,000 uni ts

EZ005Con-demand

1 x 100,000 uni ts

Purified Recombinant Human ProteinsProduct Name Reference Presentation

Recombinant human PAI-1 (native) RUO Human RP006A 1 x 10 µg

RP007A 1 x 10 µg

RP007C 1 x 1 mg

RE120A 1 x 16,000 ATU

RE120B 1 x 160,000 ATU

Purified Bovine Proteins & EnzymesProduct Name Nature Reference Presentation

Anti-thrombin (AT) RUO Bovine BP104C 1 x 10 mg

BP103A 1 x 1 mg

BP103K 6 x 1 mg

BP102A 1 x 100 µg

BP102K 6 x 100 µg

BE101C 1 x 15 µg

BE101D 1 x 30 µg

BE101L 10 x 30 µg

BE101O 1 x 50 µg

BE101K 6 x 50 µg

BE101B 1 x 0.5 mg

BP101O 1 x 10 mg

BP101K 6 x 10 mg

BP101A 1 x 100 mg

BP101B 1 x 1 g

Plasminogen RUO Bovine BP105C 1 x 5 mg

BE102A 1 x 21 NIH*

BE102K 6 x 21 NIH*

BE102B 1 x 100 NIH*

BE102C 1 x 1000 NIH*

BE501C 1 x 500 NIH*

BE501K 10 x 500 NIH*

Urokinase type Plasminogen Activator (uPA) RUO

Recombinant Hirudin RUO

Recombinant human tPA (wi ld type) RUO

Prothrombin RUO

Factor X RUO

Thrombin

Prothrombin RUO

Thrombin RUO

RUO

Human

Human

Human

Human

Bovine

tPA stimulator RUO

Human

Human

Bovine

Bovine

Bovine

Bovine

*1 NIH is equivalent to 1 International Unit (IU) (“A reunification of the US (“NIH”) and International Unit into a single standard for Thrombin”, Longstaff et al, Thromb Haemost 2005, 93:261-6).

Fibrinogen RUO

Factor Xa RUO

Purified Proteins (Continued)Purified Human Proteins and Enzymes (Continued)Product Name Nature Reference Presentation

PP006B 1 x 1 mg

PP006K 6 x 1 mg

EZ006O 1 x 10 NIH*

EZ006K 6 x 10 NIH*

EZ006A 1 x 100 NIH*

EZ006L 10 x 100 NIH*

EZ006B 1 x 1000 NIH*

PP021B 1 x 1 mg

PP021K 6 x 1 mg

EZ005Aon-demand

1 x 1,000 uni ts

EZ005Bon-demand

1 x 10,000 uni ts

EZ005Con-demand

1 x 100,000 uni ts

Purified Recombinant Human ProteinsProduct Name Reference Presentation

Recombinant human PAI-1 (native) RUO Human RP006A 1 x 10 µg

RP007A 1 x 10 µg

RP007C 1 x 1 mg

RE120A 1 x 16,000 ATU

RE120B 1 x 160,000 ATU

Purified Bovine Proteins & EnzymesProduct Name Nature Reference Presentation

Anti-thrombin (AT) RUO Bovine BP104C 1 x 10 mg

BP103A 1 x 1 mg

BP103K 6 x 1 mg

BP102A 1 x 100 µg

BP102K 6 x 100 µg

BE101C 1 x 15 µg

BE101D 1 x 30 µg

BE101L 10 x 30 µg

BE101O 1 x 50 µg

BE101K 6 x 50 µg

BE101B 1 x 0.5 mg

BP101O 1 x 10 mg

BP101K 6 x 10 mg

BP101A 1 x 100 mg

BP101B 1 x 1 g

Plasminogen RUO Bovine BP105C 1 x 5 mg

BE102A 1 x 21 NIH*

BE102K 6 x 21 NIH*

BE102B 1 x 100 NIH*

BE102C 1 x 1000 NIH*

BE501C 1 x 500 NIH*

BE501K 10 x 500 NIH*

RUO

Prothrombin RUO

Thrombin

Fibrinogen RUO

Factor Xa RUO

Human

Human

Human

Human

Thrombin RUO

tPA stimulator RUO

Human

Human

Bovine

Bovine

Bovine

Urokinase type Plasminogen Activator (uPA) RUO

Recombinant Hirudin RUO

Recombinant human tPA (wi ld type) RUO

Prothrombin RUO

Factor X RUO

Bovine

Bovine

*1 NIH is equivalent to 1 International Unit (IU) (“A reunification of the US (“NIH”) and International Unit into a single standard for Thrombin”, Longstaff et al, Thromb Haemost 2005, 93:261-6).


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Section 1:Section 10: Reseach

Others EnzymesProduct Name Reference Presentation

Protac® EZ011Bon-demand

1 x 5 uni ts

EZ008Bon-demand

1 x 10,000 uni ts

EZ008Con-demand

1 x 100,000 uni ts

Rabbit rec. Tissue Factor RE030Aon-demand

1 x 50 µgRUO

RUO

RUO

Streptokinase

Other Plasma Factor AssayProduct Name Reference Presentation

ZYMUTEST™ Annexin V RUO RK004A 96 tests

ZYMUTEST™ b2GPI RUO RK022A 96 tests

ZYMUTEST™ Fibronectin RUO RK028Aon-demand

96 tests

Chromogenic Substrates

Description and specificication Reference Presentation

229001 1 x 25 mg

229001C 12 x 25 mg

229001Z 50 x 25 mg

BIOPHEN™ CS-01(81) Thrombin Chromogenic Substrate RUO 229005 1 x 25 mg

BIOPHEN™ CS-11(32) Factor Xa Chromogenic Substrate RUO 229011 1 x 25 mg

229014 1 x 25 mg

229014C 12 x 25 mg

229014Z 50 x 25 mg

BIOPHEN™ CS-11(22) Factor Xa Chromogenic Substrate RUO 229015 1 x 25 mg

BIOPHEN™ CS-21(66) Activated Protein C Chromogenic substrate RUO 229021 1 x 25 mg

BIOPHEN™ CS-31(02) Kallicrein Chromogenic substrate RUO 229031 1 x 25 mg

BIOPHEN™ CS-41(03) Plasmin and Plasminogen-SK Chromogenic substrate RUO 229041 1 x 25 mg

BIOPHEN™ CS-61(44) Urokinase Chromogenic substrate RUO 229061 1 x 25 mg

BIOPHEN™ CS-05(88) tPA and broad spectrum Chromogenic substrate RUO 229091 1 x 25 mg

BIOPHEN™ CS-11(65) Factor Xa Chromogenic Substrate RUO

BIOPHEN™ CS-01(38) Thrombin Chromogenic Substrate RUO


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HYPHEN BioMed can also develop customized products. If you need a reagent, calibrators and controls for your project, please contact us - we may be able to help you.e-mail: [email protected], Tel: +33 (0)1 34 40 65 10

Customized Product

Other Deficient PlasmaProduct Name Reference Presentation

DP200A 1 x 1 mL

DP200K 6 x 1 mL

DP100A 1 x 1 mL

DP100K 6 x 1 mL

DP110A 1 x 1 mL

DP110K 6 x 1 mL

DP120A 1 x 1 mL

DP120K 6 x 1 mL

DP150A 1 x 1 mL

DP150K 6 x 1 mL

DP210A 1 x 1 mL

DP210K 6 x 1 mL

DP310A 1 x 1 mL

DP310K 6 x 1 mL

Animal ModelsELISA method for PAI-1 antigen and Activity in rat sample.Product Name Reference Presentation

ZYMUTEST™ rat PAI-1 (Antigen) RUO RK001Aon-demand

96 tests

ZYMUTEST™ rat PAI-1 (Activity) RUO RK003A 96 tests

Prekallikrein Deficient Plasma RUO

vWF Deficient Plasma RUO

tPA/PAI-1 Deficient Plasma RUO

Protein S Deficient Plasma RUO

Protein Z Deficient Plasma RUO

Factor XIII Deficient Plasma RUO

Protein C Deficient Plasma RUO


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IND

EX

IND

EX

Section 1:INDEX - by Reference Number -

BIOPHEN™ line BIOPHEN™ line (continued) ZYMUTEST™ line (continued) Deficient Plasmas (continued)220005................................................................34..........12 229061................................................................76......34 RK030A...............................................................15.........22 DP060A/K..........................................................17.........8220202................................................................34..........13 229091................................................................76......34 RK031A...............................................................24.........16 DP070A/K..........................................................17.........8220412................................................................14............9 Aggregometry line RK032A...............................................................13.........9, 22 DP080A/K..........................................................18.........8220502................................................................63..........24 AG001K..............................................................67......20 RK033A...............................................................14.........9 DP100A/K..........................................................19.........35221003/221006...............................................29..........13 AG002K..............................................................67......20 RK034A...............................................................15.........9 DP110A/K..........................................................19.........35221005................................................................29..........12 AG003K..............................................................67......20 RK035A...............................................................70.........18 DP120A/K..........................................................19.........35221007................................................................29..........12 AG004K..............................................................6820, 22 RK036A...............................................................11.........8 DP150A/K..........................................................19.........35221011/221013/221015...............................................29..........12, 13 AG005K..............................................................68......20 RK037A...............................................................63.........24 DP200A/K..........................................................18.........35221020................................................................30..........12 AG006A/K...............................................................6820, 22 RK038A...............................................................15.........22 DP210A/K..........................................................19.........35221030................................................................34......13 CEPHEN line RK039A...............................................................13.........22 DP310A/K..........................................................18.........35221102/221105...............................................21......16 CK511K/CK512K................................................6..........6 RK040A...............................................................31.........14 Human Enzymes221122................................................................21......16 CK515K/L..............................................................6..........6 RK040B...............................................................31.........14 EZ004B/C......................................................84........32221123/221127......................................................................16 CK521K/CK522K................................................7..........6 RK040C...............................................................31.........14 EZ005A/B/C......................................................85........33221205...............................................22.......16 FIBRIPHEN line RK040D...............................................................32.........14 EZ006O/K/A/L/B..............................................84........33221211................................................................22........16 CK571K/CK572K/CK575K.....................6 RK040E...............................................................32.........14 EZ007A/K/B/C..............................................84........32221304................................................................11............8 HEMOCLOT™ line RK041A...............................................................33.........14 EZ008B/C......................................................88........34221312................................................................12......8, 22 CK001K/L..............................................................7..........6 RK041D...............................................................33.........14 EZ010B...............................................................84........32221402/221406...............................................12......8, 22 CK002K/L...........................................................34.........13 RK042A...............................................................71.........18 EZ011B...........................................................88........34221511................................................................63......24 CK011K/L..............................................................7..........6 Auxiliary reagents EZ012A...........................................................84........32221705................................................................14............9 CK031K...............................................................23.........16 AR001A/K..........................................................57.........30 EZ014A/B...........................................................84........32221802/221806...............................................13......9, 22 CK041K...............................................................23.........16 AR002A/K..........................................................58.........30 Purified Proteins221812................................................................14............9 CK051K/L...........................................................12.........8, 9 AR004A/K..........................................................58.........30 PP001A/K/B/C/R..............................................78........32222001................................................................4512, 26 CK065K...............................................................25.........16 AR005A/K/L ........................................................58.........30 PP002A/K/B/C..................................................79........32222101................................................................44......26 CK071K...............................................................10.........8 AR006A/K..........................................................58.........30 PP003A...............................................................82........32222201................................................................4712, 26 CK081K...............................................................11.........8 AR007A/K..........................................................58.........30 PP004A/K/B/L/D/M/C....................................78........32222301................................................................4512, 26 CK090K........................................................ 26, 36.........17 AR008A/K..........................................................56.........30 PP005A/B/C......................................................80........32222401................................................................4816, 28 CK091K........................................................ 27, 36.........17 AR009A/K..........................................................56.........30 PP006B/K...........................................................81........33222501................................................................4712, 26 CK092K........................................................ 27, 36.........8, 22 AR010A...............................................................59.........30 PP007A...............................................................81........32222701................................................................5013, 27 LIAPHEN™ line AR011A/K..........................................................59.........30 PP008A...............................................................81........32222801................................................................5013, 27 120002................................................................22.........16 AR012A...............................................................56.........30 PP009A...............................................................82........32222901................................................................5013, 27 120102................................................................72.........6 AR013A...............................................................59.........30 PP010A...............................................................78........32223001/223801/224201...............................4612, 26 120206...............................................................72.........22 AR014A...............................................................56.........30 PP011A...............................................................82........32223101/223901/224101...............................4612, 26 THROMBOPHEN line AR015A..........................................................56.........30 PP012A...............................................................82........32223201................................................................44......26 CK555M.........................................................6.........6 AR015B..........................................................56.........30 PP013A...............................................................81........32223301................................................................44......26 ZYMUPHEN™ line AR016A...............................................................59.........30 PP014C...........................................................80........32223405................................................................4816, 28 521096................................................................27.........18 AR017A...............................................................59.........30 PP015A...............................................................78........32223501................................................................4712, 26 521196................................................................27.........18 AR018A...............................................................59.........30 PP016A...............................................................79........32223602/223605...............................................51......30 521296................................................................64.........24 AR019A...............................................................60.........30 PP017A...............................................................79........32223701/224301/224401...............................4612, 26 ZYMUTEST™ line AR020A...............................................................57.........30 PP018A...............................................................79........32224001................................................................4712, 26 RK001A...............................................................92.........35 AR021A/K/L......................................................58.........30 PP019A...............................................................79........32224501................................................................5113, 27 RK003A...............................................................92.........35 AR022A...............................................................57.........30 PP020A...............................................................80........32224601................................................................4422, 26 RK004A...............................................................72.........34 AR023A...............................................................60.........30 PP021B/K...........................................................80........33224701................................................................5013, 27 RK005A/B...........................................................39.........17 AR024A...............................................................60.........30 PP501B/K...........................................................80........32224801................................................................4522, 26 RK006A...............................................................71.........20 AR025A...............................................................60.........30 Recombinant Human Proteins224901................................................................4522, 26 RK007A/B...........................................................42.........17 AR026A/K..........................................................57.........30 RP006A...............................................................83........33225001................................................................4513, 27 RK008A...............................................................63.........24 AR027A...............................................................56.........30 RP007A/C..........................................................83........33225101................................................................4513, 27 RK009A...............................................................10.........8 AR028K...............................................................57.........30 Recombinant Proteins225201................................................................4513, 27 RK010A...............................................................70.........18 AR029K...............................................................58.........30 RE030A...............................................................88........34225301................................................................4513, 27 RK011A...............................................................64.........24 AR030K...............................................................58.........30 RE120A/B...............................................................93........33225401................................................................4513, 27 RK012A...............................................................62.........24 AR103A...............................................................57.........30 Standard and Controls225501................................................................4513, 27 RK013A...............................................................64.........24 AR104A...............................................................57.........30 SC011K...............................................................51........24, 28225601................................................................45......26 RK014A/B/C......................................................38.........17 Bovine Enzymes SC013K...............................................................52........20226001................................................................4513, 27 RK015A...............................................................24.........16 BE101C/D/L/O/K/B.........................................87.........33 SC015K...............................................................52........28226101................................................................4513, 27 RK016A...............................................................26.........18 BE102A/K/B/C/................................................87.........33 SC017K...............................................................5224, 28226201................................................................4513, 27 RK017A...............................................................64.........24 BE501C/K...........................................................87.........33 SC020K/L...........................................................4914, 27226301...........................................................7422, 26 RK018A...............................................................65.........24 Bovine Proteins SC025K...............................................................5014, 27226401................................................................4513, 27 RK019A...............................................................62.........24 BP101O/K/A/B.................................................86.........33 SC030K...............................................................4914, 27226501................................................................4513, 27 RK020A/B...........................................................40.........17 BP102A/K...........................................................86.........33 SC035K...............................................................4914, 27226601...........................................................74......26 RK021A...............................................................24.........16 BP103A/K...........................................................86.........33 SC050K...............................................................53........28229001/C/Z...........................................................74......34 RK022A...............................................................72.........34 BP104C...............................................................86.........33 SC081K...............................................................3617, 28229005................................................................74......34 RK023A...............................................................26.........18 BP105C...............................................................86.........33 SC082K...............................................................3617, 28229011................................................................74......34 RK024A...............................................................73.........6 Deficient plasmas SC083K...............................................................3617, 28229014/C/Z...........................................................74......34 RK025A/B...........................................................41.........17 DP010A/K..........................................................16.........8 SC101K...............................................................53........28229015................................................................75......34 RK026A/B.................................................... 39, 40.........17 DP020A/K..........................................................16.........8 SC102K...............................................................53........28229021................................................................75......34 RK027A...............................................................23.........16 DP030A/K..........................................................16.........8 SC103K...............................................................53........28229031................................................................75......34 RK028A...............................................................73.........34 DP040A/K..........................................................17.........8, 22229041................................................................75......34 RK029A/B/C......................................................37.........17 DP050A/K..........................................................17.........8, 22


IND

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Section 1:INDEX - by Product Name

A D (continued)Activated Partial Clotting Time (APTT)..................................6 Direct Thrombin Inhibitors (DTI)....................................34.................14Activated Protein C E

Chromogenic substrate..........................................................34 Edoxaban (Calibrators & Controls).....................14, 27Human enzyme.........................................................................32 Epinephrine ..........................................................................67.................20

Activators (Protac®/Streptokinase)................................................34 FActivator Diluent Factor II ..........................................see Prothrombin

Buffers and solutions for ELISA ...........................................30 Factor VSolutions for Microparticles.................................60.................30 Clotting method.......................................................10.................8

Adenosine-5’-diphosphate (ADP).................................67.................20 Deficient plasma .....................................................16.................8Aggregometry......................................................................67.................20 Elisa kit.........................................................................10.................8Alpha 2 anti-plasmin (chromogenic assay)................63.................24 Factor V-LeidenAnti-IIa activity Calibrator................................................... 16, 28

See Direct Thrombin Inhibitors...........................34.................13 Clotting method.......................................................25.................16See Heparins and their analogues............................................................... 30.................12 Control.......................................................16, 28See Thrombophilia ................................................ 21.................16 Factor VII

Anti-VIII Chromogenic assay.................................................11.................8Elisa kit.........................................................................13.................22 Clotting method.......................................................11.................8

Anti-Xa activity Deficient plasma......................................................16.................8See Direct FXa Inhibitors...........................34.................13 Elisa kit.........................................................................11.................8See Heparins and their analogues...................................................12 Human protein..........................................................81.................32

Annexin V Factor VIIaControl.......................................................24, 28 Chromogenic assay...................................... 8, 22Elisa kit.........................................................................72.................34 Clotting method........................................... 8, 22

Anti-Annexin V auto antibodies.....................................39.................17 Calibrator and control............................. 8, 22, 26Anti-β2GP1 auto-antibodies...........................................38.................17 Factor VII-X (Clotting method)............................. 8, 9Anti-cardiolipin/Anti-Phospholipid Factor VIII:Cantibodies (ACA/APA)........................................................37.................17 Chromogenic assay...................................... 9, 22Anti-Protein C auto-antibodies...............................39, 40.................17 Deficient plasma ......................................... 8, 22Anti-Protein S auto-antibodies.......................................40.................17 Factor IXAnti-Protein Z auto-antibodies......................................41.................17 Chromogenic assay..................................... 9, 22Anti-Prothrombin auto-antibodies...............................42.................17 Deficient plasma......................................... 8, 22Antithrombin III Elisa kit....................................................... 9, 22

Bovine protein...........................................................86.................33 Human protein..........................................................81.................32Buffers..........................................................................57.................30 Factor IXaChromogenic assay.................................................21.................16 Chromogenic assay ......................................9, 22Latex Immuno-assay...............................................22.................16 Chromogenic substrate.............................................................34Human protein..........................................................78.................32 Control.......................................................22, 26

Apixaban (Calibrators & Controls).....................14, 27 Human enzyme........................................................84.................34Argatroban (Calibrator & Control).....................14, 27 Factor XArachidonic Acid.................................................................67.................20 Bovine protein...........................................................86.................33Arixtra® (Calibrator & Control)......................... 12, 26 Chromogenic assay ................................................14.................9Autoimmunity sample diluent.......................................59.................30 Deficient plasma......................................................17.................8B Elisa kit.........................................................................14.................9β2GP1 Human protein..........................................................81.................32

Buffer and solutions for ELISA.............................60.................30 Factor XaElisa kit.........................................................................72.................34 Bovine enzyme.........................................................87.................33Human protein..........................................................78.................32 Chromogenic assay .................................... 12, 13

Bentonite................................................................................60.................30 Chromogenic substrate......................................74, 7534C Human enzyme........................................................84.................32C4b-BP (human protein)...................................................78.................32 Factor XICalcium Chloride...........................................................57, 58.................30 Deficient plasma......................................................17.................8Calcium Thromboplastin.....................................................6.................6 Factor XIaCalibrators..............................................................................43.................25 Chromogenic assay ................................................14.................9Collagen..................................................................................68.................20 Factor XIICollagen Binding Assay (CBA) ........................................15.................22 Deficient plasma......................................................18.................8Control plasmas...................................................................43.................25 Factor XIIaConjugate Diluent...............................................................59.................30 Human Enzyme........................................................84.................32C-Reactive Protein (CRP) Factor XIII

Elisa kit.........................................................................70.................18 Deficient plasma......................................................18.................35D Elisa kit.........................................................................15.................9Dabigatran (Calibrators & Controls).....................14, 27 Fibrin (fragment)..................................................................80.................32D-Dimer Fibrinolysis sample diluent..............................................59.................30

Controls.........................................................................53.................28 Fibrino Peptide A (FPA)Elisa kit.........................................................................26.................18 Buffer and solutions for ELISA.............................59.................30

Deficient Plasmas......................................... 8, 22, 35 Elisa kit.........................................................................26.................18Dilution buffers....................................................................59.................30 Control.........................................................................52.................28

IND

EX

Section 1:INDEX - by Product Name -


F (continued) P (continued)Fibrinogen Protein C

Bovine protein...........................................................86.................32 Chromogenic assay.................................................22.................16Buffer and solutions for ELISA.............................60.................30 Clotting method.......................................................23.................16Elisa kit.....................................................................8, 73.................6 Deficient plasma......................................................19.................35Human protein...................................................78, 79.................32 Elisa kit.........................................................................23.................16

see Prothrombin Fragments D, DD, E, E3t ........................................79.................32 Human protein..........................................................82.................32Latex immuno-assay...........................................8, 72.................6 Protein SVon Clauss Method....................................................8.................6 Clotting method.......................................................23.................16

Fibronectin Control.........................................................................53.................28Elisa kit.........................................................................73.................34 Deficient plasma......................................................19.................35Buffer and solutions for ELISA.............................60.................30 Elisa kit (Free & Total)..............................................24.................16

H Human protein..........................................................82.................32Heparin Protein Z

Chromogenic assay..........................................29, 30.................12 Deficient plasma......................................................19.................35Calibrators and Controls..............................12, 26 Elisa kit.........................................................................24.................16

Heparin CoFactor II Human protein..........................................................82.................32Human protein..........................................................80.................32 Prothrombin

Heparin dependent antibodies (Elisa kit)....... 31 to 33.................14 Bovine protein...........................................................86.................33Hirudin Buffer and solutions................................................57.................30

Calibrators and Control............................. 14, 27 Deficient plasma......................................................16.................8Recombinant Hirudin.............................................88.................33 Human protein..........................................................81.................33

I Prothrombin Time (PT)Imidazole buffer...................................................................58.................30 Clotting method..........................................................6.................6K RKallikrein (Chromogenic substrate)..............................75.................34 Ristocetin....................................................... 20, 22L Rivaroxaban (Calibrators & Controls)..................13, 27Low Molecular Weight Heparin S

Calibrators and Controls............................ 12, 26 Sample Diluents............................................................59, 60.................30Lupus Anticoagulant Stop Solution........................................................................60.................30

Clotting method................................................26, 36.................17 Streptokinase........................................................................88.................34Controls.................................................... 17, 28 Substrates....................................................... 30, 34

Lyophilized platelets....................................... 20, 22 TM Thrombin Activatable Fibrinolysis Inhibitor (TAFI)Microparticles’ coagulant activity..................................27.................18 Elisa kit........................................................................63,.................24N ThrombinNon titrated human plasmas (Chromogenic assay)...........5130 Bovine enzyme.........................................................87.................33O Chromogenic substrate.........................................74.................34Orgaran® (Calibrator & Control)....................... 12, 26 Clotting method..........................................................7.................6P Human enzyme........................................................84.................33Phosphate-NaCl buffers....................................................58.................30 Thrombin Time (T.T.)..............................................................7.................6Plasminogen Activator Inhibitor-1 (PAI-1) Tissue Factor

Control.......................................................24, 28 Elisa kits................................................................70, 71.................18Elisa kit (Activity & Antigen)...........................62, 65.................24 Recombinant, rabbit...............................................88.................34Elisa kit (animal model)..........................................92.................35 Tissue Plasminogen Activator (tPA)Protein (Animal model)..........................................93.................34 Elisa kits (Antigen & Activity)........................64, 65.................24Recombinant human protein..............................83.................33 Control.....................................................52, 54.................24, 28Deficient plasma (tPA/PAI-1)................................19.................35 Recombinant human protein..............................83.................33

Platelet aggregation....................................................67, 68.................20 Deficient Plasma (tPA/PAI-1)................................19.................35Para-Nitro-Aniline (PNA)...................................................56.................30 tPA and broad spectrum (Chrom. Substrate)............76.................34Plasma factors and cofactors (Chromogenic assay) .........................................................4426 tPA stimulator.......................................................................80.................33Plasmin Tetra-Methyl Benidine (TMB)..........................................59.................30

Chromogenic substrate....................................................75.................34 Tris buffers..............................................................................57.................30Human enzyme....................................................................85.................32 U

Plasminogen Unfractionated HeparinBovine protein...........................................................86.................33 Calibrators and Controls............................ 12, 26Chromogenic assay..........................................62, 63.................24 Urokinase (Chromogenic substrate)............................76.................34Human protein..........................................................79.................32 Urokinase-type Plasminogen Activator (uPA)

Platelet Factor 4 (PF4) Control.......................................................24, 28Control.........................................................................52.................20 Elisa kits.......................................................................64.................24Elisa kit.........................................................................71.................20 Human enzyme........................................................85.................33Human protein..........................................................82.................32 V

Prekallikrein von Willebrand Factor (vWF)Deficient plasma......................................................18.................35 Deficient plasma......................................................19.................35Human protein..........................................................80.................32 Elisa kit.........................................................................15.................22

Protac® ....................................................................................88.................34 Latex immuno-assay...........................................8, 72.................22WWash solutions..............................................................58, 60.................30

HYPHEN BioMed S.A.S. 155 rue d’Eragny 95000 NEUVILLE-SUR-OISE France • Tél: +33 (0)1.34.40.65.10 • Web : www.hyphen-biomed.com

Lire attentivement les instructions figurant sur l’étiquetage et/ou la notice d’utilisation des réactifs.Read carefully the instructions appearing on the label and / or instructions for use of the reagents.

HYPHEN BioMed155 rue d’Eragny 95000 Neuville sur Oise, France • Tel: +33 (0)1.34.40.65.10 • [email protected] • www.hyphen-biomed.com

More information on HYPHEN BioMed and product catalog is available at : www.hyphen-biomed.com

Please note that this catalogue contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. For more information, please contact our local representatives in your country. http://www.hyphen-biomed.com/index.php/en/ordering-info/distributors-list

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A Company of Sysmex Group Hemostasis Product Catalogue · 1 Company Overview Innovation and Expertise in Hemostasis HYPHEN BioMed is a French company which is internationally recognized