Device Dossier

Coagulation calibrator/control IVDs

Device Dossier for Coagulation calibrator/control IVDs (CT872 - Coagulation calibrator/control IVDs, Class 2, sponsor Helena Laboratories). ARTG record,…

Intended purpose

Calibrators and controls intended for use in coagulation studies. IVDs that are intended to be used in testing to establish known points of reference and/or verify the perfomance of coagulation assays.

TGA Public Summary