BIOPHEN™ Heparin Calibrator
BIOPHEN™ Heparin Calibrator
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Product Summary:
BIOPHEN™ Heparin Calibrator (222001) is a calibration set of plasmas for the assay of Heparins (UFH and LMWH) with anti-Xa method. Manufactured by HYPHEN BioMed.
Intended Use
For calibration of Low Molecular Weight Heparin (LMWH) assays and Unfractionated Heparin (UFH) assays when the superposition (LMWH/UFH) is validated, using a quantitative automated method.
This device of in vitro diagnostic use is intended for professional use in the laboratory.
Summary and ExplanationTechnical These calibrators are used to establish the calibration curve of LMWH in plasma by anti-Xa chromogenic assays (BIOPHEN™ Heparin LRT).
Clinical Measuring the heparin concentration in patients’ plasma can be used for monitoring the therapy and adjusting drug dosage.
ReagentsCAL1 Lyophilized human plasma without LMWH. CAL2 Lyophilized human plasma containing approximately 0.4 IU/mL of LMWH. CAL3 Lyophilized human plasma containing approximately 0.8 IU/mL of LMWH. CAL4 Lyophilized human plasma containing approximately 1.2 IU/mL of LMWH. CAL5 Lyophilized human plasma containing approximately 1.6 IU/mL of LMWH.
Calibrator plasmas contain stabilizing agents.
The calibrator concentrations may vary slightly from one batch to another. For the assay, see the exact values indicated on the flyer provided with the kit used.
The product is classified as non-hazardous and is not subject to labeling according to EC Regulation No. 1272/2008 [CLP].
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Product RangeProduct Code222001Product NameBIOPHEN™ Heparin CalibratorProduct CategoryProduct BrandProduct Analyte or ApplicationProduct Size5 x 4 x 1 mlProduct Storage2°C to 8°CProduct IVD Registration Status510(k),CE-Mark - Professional Use
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