Device Dossier
Coagulation factor IVDs
Device Dossier for Coagulation factor IVDs (CT877 - Coagulation factor IVDs, Class 3, sponsor Medtronic). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT877 - Coagulation factor IVDs
Intended purpose
The devices are point of care in vitro diagnostic coagulation test cartridges and coagulation controls to measure activated clotting time and monitor the anticoagulation effect of heparin.