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

IVDs that use chemiluminescence Immunoassay (CLIA) technology for the determination of specific antibodies to SARS-CoV-2 in human serum or plasma.

TGA Public Summary