Device Dossier
Rubella virus IVDs
Device Dossier for Rubella virus IVDs (CT771 - Rubella virus IVDs, Class 3, sponsor Beckman Coulter). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT771 - Rubella virus IVDs
Intended purpose
The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.