HEMOCLOTâ„¢ Quanti-V-L
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HEMOCLOTâ„¢ Quanti-V-L

Code: ACK065K
Manufacturer’s Part Number: CK065K
Product size: Kit
Clearance: 510(k)
Price: $385.00
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Product Description

For In Vitro Diagnostic Use.

HEMOCLOT™ Quanti VL is the ONLY quantitative APC Resistance assay available. Clotting method using Factor V-deficient plasma substrate that eliminates interference from other coagulation variables. Calculates a normalized APC Sensitivity Ratio (APC-SR) that discriminates: normal (APC-SR >2.0), heterozygous FV Leiden (APC-SR ~1.5), and homozygous FV Leiden (APC-SR ~1.0) — without genetic testing. For thrombophilia screening: FV Leiden is the most common inherited thrombophilia (3-8% of Caucasians). Heterozygous = 5x VTE risk; homozygous = 50-80x VTE risk. Also detects acquired APC resistance (pregnancy, OCP, lupus anticoagulant). FDA 510(k) cleared. CE-IVD.

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

Certificate of Analysis (COA)

Other Documents