BIOPHEN™ UFH Calibrator
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BIOPHEN™ UFH Calibrator (222301) is a calibrator set for the calibration of Unfractionated Heparin (UFH) assays, using a quantitative automated method. Manufactured by HYPHEN BioMed.
Intended Use
For calibration of Unfractionated Heparin (UFH) 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 UFH 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.
Reagents
CAL1 Lyophilized human plasma without UFH.
CAL2 Lyophilized human plasma containing approximately 0.35 IU/mL of UFH.
CAL3 Lyophilized human plasma containing approximately 0.65 IU/mL of UFH.
CAL4 Lyophilized human plasma containing approximately 1.00 IU/mL of UFH.
CAL5 Lyophilized human plasma containing approximately 1.30 IU/mL of UFH.
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 labelling according to EC Regulation No. 1272/2008 [CLP].
CE-Mark - Professional Use
UKCA
