Device Dossier

General coagulation IVDs

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

Intended purpose

A whole Blood Microcoagulation point-of-care coagulation test for fresh or citrated whole blood. Tests typically include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate).

TGA Public Summary