Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Sonictec). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
This device is used for the qualitative detection of influenza A virus, influenza B virus, COVID-19, human metapneumovirus, respiratory syncytial virus and adenovirus antigens in nasal swab specimens from symptomatic individuals. This is a rapid antigen test intended for self-testing by lay users.