Code: ACK065K
Manufacturer’s Part Number: CK065K
Product size: Kit
Clearance: 510(k)

Price: $350.00


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.

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

Product Applications

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.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Other Documents