Device Dossier

Severe acute respiratory syndrome-associated coronavirus IVDs

Device Dossier for Severe acute respiratory syndrome-associated coronavirus IVDs (CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs,…

Intended purpose

the 2019-n-CoV IgG/IgM Rapid Test Cassette is a lateral flow Chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood , serum or plasma specimens

TGA Public Summary