PT Calibrator Set
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PT Calibrator Set (SC084K) is a set of five certified plasmas for PT/INR and PT% calibration and/or for verification of local ISI test system. Manufactured by HYPHEN BioMed.
Intended Use
PT Calibrator set is a set of five plasmas for PT% calibration.
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 for PT% assays with (h)PT-Phen™ and PT-Phen™ LRT in human plasma clotting. The various levels are obtained by mixing a normal plasma pool and normal plasma partially depleted in different factors of prothrombin complex.
Clinical PT assesses the overall activity of clotting factors of the extrinsic pathway (Factor II, V, VII, X and fibrinogen).
Reagents
CAL1 Lyophilized human plasma with PT% value over 90% CAL2 Lyophilized human plasma with PT% value at approximately 65% CAL3 Lyophilized human plasma with PT% value at approximately 45% CAL4 Lyophilized human plasma with PT% value at approximately 28% CAL5 Lyophilized human plasma with PT% value less than 20%
Calibrator plasmas contain stabilizing agents.
The PT% assigned values 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].
UKCA
