Device Dossier

General coagulation IVDs

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

Intended purpose

Randox Laboratories Ltd produce a range of kits, calibrators, controls and test reagents intended to provide information about the general coagulation of blood and the time taken for a clinical blood specimen to clot following initiation of the intrinsic and/or extrinsic coagulation pathways.

TGA Public Summary