Device Dossier

General coagulation IVDs

Device Dossier for General coagulation IVDs (CT871 - General coagulation IVDs, Class 2, sponsor Elitechgroup). ARTG record, intended purpose, GMDN…

Intended purpose

IVDs is intended for use as a normal control for one-stage prothrombin time (PT)and activated partial thromboplastin time (APTT) assays.