BIOPHEN™ Heparin 3
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BIOPHEN™ Heparin 3

Code: A221003
Manufacturer’s Part Number: 221003
Product size: 3 x 3.75 mL
Clearance: 510(k)
Price: Discontinued
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Product Description

For In Vitro Diagnostic Use.

510(k) Cleared for In Vitro Diagnostic Use for UFH only.

Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) using the same calibration curve (kinetics method, one stage). The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.

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 interference 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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