Device Dossier
Toxoplasma IVDs
Device Dossier for Toxoplasma IVDs (CT820 - Toxoplasma IVDs, Class 3, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: CT820 - Toxoplasma IVDs
Intended purpose
Immunoassays for the in vitro qualitative determination of IgG antibodies, the qualitative determination of the avidity of IgG antibodies and the qualitative determination of IgM antibodies to Toxoplasma gondii, including their respective control materials in human serum and plasma