Device Dossier
General coagulation IVDs
Device Dossier for General coagulation IVDs (CT871 - General coagulation IVDs, Class 2, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT871 - General coagulation IVDs
Intended purpose
Intended to be used along with Optical Coagulation Analyzer to provide quantitative measurement of Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, Activated Clotting Time, Thrombin Time and Prothrombin Time PT/International Normalized Ratio (INR) in citrated venous whole blood. For in vitro diagnostic use only. For professional use only.