Clotting assay for quantitative determination of Factor V Leiden (FV-L) by measuring APC resistance in the presence of Protein S, in human citrated plasma. CE-IVD / 510(k).

Factor V Leiden mutation is the most common hereditary thrombophilia risk factor — increasing venous thrombosis risk 3–8×. This is the only quantitative APC resistance assay available, measuring %FV-L concentration directly, not just a screening ratio.

• Quantitative — measures %FV-L, distinguishes homozygous from heterozygous
• Performed in presence of Protein S for physiological conditions
• Requires BIOPHEN™ V-L Plasma Calibrator (ref. 222401)
• CE-IVD and 510(k) cleared