Device Dossier

Coagulation factor IVDs

Device Dossier for Coagulation factor IVDs (CT877 - Coagulation factor IVDs, Class 2, sponsor Helena Laboratories). ARTG record, intended purpose, GMDN…

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of individual clotting factors within the coagulation cascade.

TGA Public Summary