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

This kit is used for in vitro qualitative detection of novel coronavirus (COVID-19) IgM / IgG antibodies in human serum, plasma, and whole blood samples. It is only used as a supplementary indicator for suspected cases negative for novel corona virus detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. The test results can NOT be the only basis for diagnosis or exclusion of the coronavirus caused pneumonia. The detection kit is not applicable to general population screening.

TGA Public Summary