dZ/DZKŝĂŐŶŽƐƟĐƐ^> ĐsĂůğŶĐŝĂϱϱϴϰƚϮĂ-ϬϴϬϮϲĂƌĐĞůŽŶĂ

нϯϰϵϯϮϰϰϴϲϳϵ-ŝŶĨŽΛϯĚŝĂŐĐŽŵ

E/&^ϲϲϳϯϵϳϳϮ

dZ/DZKŝĂŐŶŽƐƟĐƐ^>-ƉƉůŝĐĂƟŽŶWƌŽƉŽƐĂůhϰϬϬ-hϰϴϬ-hϲϰϬ-ϯĚŝĂŐ-/Ő-d®-;ƌĞǀE-ϬϵϬϴϮϬϭϴͿ-ƉĂŐĞϭŽĨϭ

ϯĚŝĂŐ-/Ő-d® /Ő/ŵŵƵŶŽŐůŽďƵůŝŶƐ-ĨŽƌdƵƌďŝĚŝŵĞƚƌLJ

d-ϰϮϴϭϭ

/&hEEy hϰϬϬ-hϰϴϬ-hϲϰϬƉƉůŝĐĂƟŽŶ

Specific Test Parameters General LIH ISE Range Test Name: IGE Ñ < > Type: Serum Ñ Operation: Yes Ñ Sample: Volume 7.0 mL Dilution 0 mL Pre-Dilution Rate: 1 Reagents: R1 Volume 160 mL Dilution 0 mL Min OD Max OD R2 Volume 60 mL Dilution 10 mL L H Reagent OD limit: Wavelength: Pri. 600 Ñ Sec. None Ñ First L -2.0 First H 2.5 Method: FIXED Ñ Last L -2.0 Last H 2.5 Reaction slope: + Ñ Dynamic Range: Measuring Point 1: First 12 Last 27 L ** H ** Measuring Point 2: First Last Correlation Factor: Linearity : % A 1.00 B 0.00 No Lag Time: Ñ On-board stability period: #

Specific Test Parameters General LIH ISE Range Test Name: IGE Ñ < > Type: Serum Ñ Value/Flag: # Ñ Level L: # Level H: # Normal Ranges: Age L Age H Sex Year Month Year Month L H o 1. # Ñ # # # # # # o 2. # Ñ # # # # # # o 3. # Ñ # # # # # # o 4. # Ñ # # # # # # o 5. # Ñ # # # # # # o 6. # Ñ # # # # # # 7. None Selected # # 8. Out of Range L H # # Panic Value: # # Unit: IU/mL Decimal places: #

Calibration Specific General ISE Test Name: IGE Ñ < > Type Serum Ñ Calibration Type: 6AB Ñ Formula: See Note (a) Ñ Counts: # Process: Ñ Cal. No. OD CONC Factor/OD-L Factor/OD-H Point 1: 1 ** -2.0 2.5 Point 2: 2 ** -2.0 2.5 Point 3: 3 ** -2.0 2.5 Point 4: 4 ** -2.0 2.5 Point 5: 5 ** -2.0 2.5 Point 6: 6 ** -2.0 2.5 Point 7: 1-Point Cal. Point: o With CONC-0 MB Type Factor: # Calibration Stability Period: #

# User defined ** Lot specific, see the analytical values table of the IFU of the Calibrators (a) User defined, SPLINE (recommended) or POLYGONAL