Device Dossier

Toxoplasma IVDs

Device Dossier for Toxoplasma IVDs (CT820 - Toxoplasma IVDs, Class 3, sponsor Beckman Coulter). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

The Access Toxo IgG/IgM assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.

TGA Public Summary