Device Dossier
Special coagulation IVDs
Device Dossier for Special coagulation IVDs (CT873 - Special coagulation IVDs, Class 2, sponsor Sysmex). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT873 - Special coagulation IVDs
Intended purpose
An in vitro diagnostic reagent for the quantitative determination of activity, such as C1-inhibitor activity, as an aid to diagnosis and monitoring of congenital or acquired deficiencies in patients at risk in human sodium citrated plasma by means of automated chromogenic methods.