Device Dossier
Coagulation factor IVDs
Device Dossier for Coagulation factor IVDs (CT877 - Coagulation factor IVDs, Class 2, sponsor Werfen). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT877 - Coagulation factor IVDs
Intended purpose
HemosIL AcuStar VWF:CB (PN/0009802044) – CT877 – IVD Class 2 Intended Use: HemosIL AcuStar von Willebrand Factor Collagen Binding Activity assay (HemosIL AcuStar VWF:CB) is a fully automated chemiluminescent immunoassay for the quantitative determination of von Willebrand Factor Collagen Binding Activity in human citrated plasma on the ACL AcuStarTM. The HemosIL AcuStar VWF:CB assay is indicated for use on patients who are suspected of having von Willebrand Disease (VWD).