Device Dossier
Coagulation factor IVDs
Device Dossier for Coagulation factor IVDs (CT877 - Coagulation factor IVDs, Class 2, sponsor Letap Solutions). ARTG record, intended purpose, GMDN…
- GMDN category: CT877 - Coagulation factor IVDs
Intended purpose
The Collagen Binding Assay ELISA kit (CBAE-1) manufactured by DSRV INC is intended to be used for the qualitative determination of von Willebrand factor in plasma samples.