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 product is used for the qualitative detection of COVID-19 (2019-nCoV), Influenza A (Flu A), Influenza B (Flu B), and Respiratory Syncytial Virus (RSV) antigens in human nasal swab specimens from symptomatic individuals as an aid for diagnosis (Self-testing).

TGA Public Summary