Device Dossier

Thrombophilia and coagulation inhibitor IVDs

Device Dossier for Thrombophilia and coagulation inhibitor IVDs (CT876 - Thrombophilia and coagulation inhibitor IVDs, Class 2, sponsor Sysmex). ARTG…

Intended purpose

In vitro diagnostic reagents for the quantitative determination of thrombosis, abnormal development of cloths and inhibitors of the coagulation process activity, such as Antithrombin or Protein C, as an aid to diagnosis and monitoring of congenital or acquired deficiencies in patients.

TGA Public Summary