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 —…

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.

TGA Public Summary