Device Category Dossier

CT876 - Thrombophilia and coagulation inhibitor IVDs

Device Category Dossier for CT876 - Thrombophilia and coagulation inhibitor IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs
Device: Thrombophilia and coagulation inhibitor IVDs

Thrombophilia and coagulation inhibitor in vitro diagnostic devices use qualitative or quantitative nucleic acid and protein assays to detect genetic mutations and measure activity levels in coagulation factors and related proteins such as Factor V, Factor II, antithrombin, and protein C in human blood and plasma samples. These devices are used to aid in assessing the risk of thrombotic disease and diagnosing congenital or acquired coagulation disorders in patients suspected of having thrombophilia or abnormal clotting.