Device Dossier
Rubella virus IVDs
Device Dossier for Rubella virus IVDs (CT771 - Rubella virus IVDs, Class 3, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT771 - Rubella virus IVDs
Intended purpose
Immunoassays for the qualitative determination of IgM and IgG antibodies to Rubella virus (two separate assays). Intended for use on Elecsys and cobas e immunoassya analysers