HEMOCLOT™ Quanti.VL is the only quantitative Activated Protein C (APC) resistance assay available — measuring Factor V Leiden (FV-L) concentration directly as a percentage, performed in the presence of Protein S in human citrated plasma.

Factor V Leiden is the most common hereditary thrombophilia risk factor, increasing venous thrombosis risk 3-8x in heterozygotes and up to 80x in homozygotes. Unlike qualitative APC resistance ratios, HEMOCLOT™ Quanti.VL distinguishes heterozygous from homozygous FV-L without requiring DNA testing.

Calibrated with BIOPHEN™ V-L Plasma Calibrator and validated with BIOPHEN™ V-L Control Plasma. FDA 510(k) cleared and CE-IVD marked.


Reference Product Name Price
510(k)
ACK065K
HEMOCLOT™ Quanti.VL — Quantitative APC Resistance / Factor V Leiden $385.00
510(k)
A222401
BIOPHEN™ V-L Plasma Calibrator — Factor V Leiden Quantitative Calibrator $102.00
510(k)
A223405
BIOPHEN™ V-L Control Plasma — Factor V Leiden QC (Heterozygous APC-R) $175.00
510(k)
A223201
BIOPHEN™ Normal Control Plasma — Multi-Parameter QC (22 Analytes) $175.00
RUO
A223201-RUO
BIOPHEN™ Normal Control Plasma — Multi-Parameter QC (22 Analytes) $175.00
CE  /  HCL
A223201-CAN
BIOPHEN™ Normal Control Plasma — Multi-Parameter QC (22 Analytes) $175.00