Device Dossier
General coagulation IVDs
Device Dossier for General coagulation IVDs (CT871 - General coagulation IVDs, Class 2, sponsor Helena Laboratories). ARTG record, intended purpose, GMDN…
- GMDN category: CT871 - General coagulation IVDs
Intended purpose
Reagents and kits intended for use in general coagulation studies such as the determination of thrombin time, fibrinogen, aPTT, prothrombin time and Antithrombin Xa.IVDs that are intended to be used in testing to provide information about the general coagulation of blood and the time taken for a clinical blood specimen to clot following initiation of the intrinsic and/or extrinsic coagulation pathways.