BIOPHEN™ Heparin 6 — Anti-Xa Assay for UFH/LMWH/Analogues
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BIOPHEN™ Heparin 6 — Anti-Xa Assay for UFH/LMWH/Analogues

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

Anti-Xa chromogenic assay for unfractionated heparin (UFH) and low molecular weight heparin (LMWH) using the same calibration curve. Kinetics (one-stage) method. Also validated for heparin analogues — Orgaran® (Sodium Danaparoïd) and Arixtra® (Fondaparinux). Automatic or manual method. CE-IVD / 510(k).

  • Validated interference data: no significant interference from bilirubin <0.1 mg/mL, Hgb <2 mg/mL, or triglycerides <1.25 mg/mL
  • Lyophilized format — 4 × 6 mL

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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