BIOPHEN™ Heparin 6
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BIOPHEN™ Heparin 6

Code: A221006
Manufacturer’s Part Number: 221006
Product size: 4 x 7.5 mL
Clearance: 510(k)
Price: $439.00
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Product Description

For In Vitro Diagnostic Use.

BIOPHEN™ Heparin 6 is a lyophilized chromogenic anti-Xa assay for heparin and direct FXa inhibitor monitoring. Same analyte coverage as Heparin LRT (UFH, LMWH, fondaparinux, danaparoďd, rivaroxaban, apixaban, edoxaban). Lyophilized format requires reconstitution but offers longer shelf life. FDA 510(k) cleared and CE-IVD.

Product Characteristics

  • Total Assay Time: < 3 min
  • Detection Threshold: 0.05 IU/mL
  • Dynamic Range: 0 to 2 IU/mL
  • Intra-Assay CV: < 3%
  • Inter-Assay CV: < 5%
  • No significant interfernce observed for Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations < 2 mg/mL and triglycerides concentrations < 1.25 mg/mL added to plasma.

Product Components

  

Product Applications

Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents

  

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