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

Assays intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection.

TGA Public Summary