$361.00
In US: 510(k) Cleared for In Vitro Diagnostic Use. Product information and documentation available online.
PRODUCT DESCRIPTION
In US: 510(k) Cleared for In Vitro Diagnostic Use. Clotting method for the quantitative measurement of Factor V-L (Factor V Leiden) concentration in citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein C and Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.
In US: 510(k) Cleared for In Vitro Diagnostic Use. Product information and documentation available online.
PRODUCT CHARACTERISTICS
Total Assay Time: < 5 min Detection Threshold: < 1% Dynamic Range: 0 to 100% Intra-Assay CV: < 3% Inter-Assay CV: < 5% No Significant Interference of Heparin, Bilirubin, Hemoglobin
PRODUCT COMPONENTS
R1: 3 x 2 mL Clotting mi x ture. (h-Fibrinogen, h-Prothrombin and Protein S).
R2: 3 x 1 mL FXa and phospholipids.
Video of Product Components
PRODUCT APPLICATION
Quantitative measurement of FV-L, resistant to the action of Activated Protein C, for diagnosing patients carrying the R506Q FV mutation (Factor V-Leiden), or any FV mutant resistant to APC.
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