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

TaqPath™ COVID-19 Kits contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

TGA Public Summary