Device Category Dossier

CT877 - Coagulation factor IVDs

Device Category Dossier for CT877 - Coagulation factor IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Coagulation factor in vitro diagnostics are intended for the qualitative and quantitative determination of individual clotting factors within the coagulation cascade. These devices aid diagnosis and monitoring of congenital or acquired deficiencies in patients with bleeding disorders or at risk for deficiency.