PRODUCT DESCRIPTION

In US: For Research Use Only. Not for Use in Diagnostic Procedures. Chromogenic assay for the measurement of Factor IX activity in human citrated plasma or Factor IX concentrates. Automated or Manual Method. Calibrator plasma and controls (at two levels) are available. This assay offers two working ranges for Factor IX (Low: 0 to 20% and High: 5 to 200%). For purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma is recommended. Replaces product code A221805.

For the measurement of Factor IX activity in research applications.

PRODUCT CHARACTERISTICS

Total Assay Time: 10 min

Detection Threshold:

High Range: 2%

Low Range: 0.5%

Dynamic Range:

High Range: 5 to 200%

Low Range: 1 to 20%

Intra-Assay CV: 3 to 5%

Inter-Assay CV: 4 to 6%

Number of Tests (Manual Microplate Method): 2 x 120 Tests

Reference Material: NIBSC International standard

Reference Material: NIBSC International standard

PRODUCT COMPONENTS

R1: 2 x 6 mL Human FX and FVIII:C, lyophilized.

R2: 2 x 6 mL Activation Reagent, lyophilized.

R3: 2 x 6 mL Chromogenic substrate specific for FXa (SXa-11), lyophilized.

R4: 4 x 25 mL Tris-BSA Buffer, ready to use.

PRODUCT APPLICATION