Device Category Dossier

CT702 - Multiple-viruses IVDs

Device Category Dossier for CT702 - Multiple-viruses IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Lateral flow immunoassay devices detect viral nucleoprotein antigens from nasal swab specimens using immunochromatographic methods to qualitatively identify multiple respiratory viruses including SARS-CoV-2, influenza A and B, respiratory syncytial virus, adenovirus, and human metapneumovirus. These tests aid in diagnosis of symptomatic individuals with suspected respiratory infection, typically within the first 7 days of symptom onset for COVID-19 and within the first 4 days for influenza, adenovirus, or respiratory syncytial virus.