Device Category Dossier

CT872 - Coagulation calibrator/control IVDs

Device Category Dossier for CT872 - Coagulation calibrator/control IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Coagulation calibrator/control in vitro diagnostic devices are intended to be used in testing to establish known points of reference and/or verify the performance of coagulation assays. These devices are used for calibration and quality control of coagulation testing, including monitoring precision and detecting analytical deviations in assays such as antithrombin, prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, D-dimer, and fibrin degradation products.