BIOPHEN™ Arixtra® Calibrator
BIOPHEN™ Arixtra® Calibrator
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Product Summary:
BIOPHEN™ Arixtra® Calibrator (222501) is a Calibrator Set for Arixtra® in Plasma. Manufactured by HYPHEN BioMed.
Intended Use
For calibration of Arixtra® (Fondaparinux) assays, using a quantitative automated method.
This device of in vitro diagnostic use is intended for professional use in the laboratory.
Summary and Explanation
Technical These calibrators are used to establish the calibration curve of Arixtra® in plasma by anti-Xa chromogenic assays (BIOPHEN™ Heparin LRT).
Clinical Measuring the Arixtra® concentration in patients’ plasma can be used for monitoring the therapy and adjusting drug dosage.
Reagents
CAL1 Lyophilized human plasma without Arixtra®. CAL2 Lyophilized human plasma containing approximately 0.5 µg/mL of Arixtra®. CAL3 Lyophilized human plasma containing approximately 1.0 µg/mL of Arixtra®. CAL4 Lyophilized human plasma containing approximately 1.5 µg/mL of Arixtra®.
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 Code222501Product NameBIOPHEN™ Arixtra® CalibratorProduct CategoryProduct BrandProduct Analyte or ApplicationProduct Size4 x 3 x 1 mlProduct Storage2°C to 8°CProduct IVD Registration StatusCE-Mark - Professional Use
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