Device Category Dossier

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Device Category Dossier for CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs. Australian ARTG records, sponsors, device class —…

Rapid antigen tests for

COVID-19 are visual immunoassays that directly and qualitatively detect viral SARS-CoV-2 nucleoprotein antigens in nasal swabs through a non-automated procedure. These tests are intended for personal self-testing use by people aged 2 and over who are suspected of COVID-19 infection, particularly within the first 7 days of symptom onset.