Device Dossier
General coagulation IVDs
Device Dossier for General coagulation IVDs (CT871 - General coagulation IVDs, Class 2, sponsor Diagnostica Stago). ARTG record, intended purpose, GMDN…
- GMDN category: CT871 - General coagulation IVDs
Intended purpose
The QPlus® Cartridge and the QStat® Cartridge are intended for in vitro diagnostic use with the Quantra® Hemostasis Analyzer. The QPlus and the QStat is a multi-channel cartridge that provide semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample.