Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor BIO TOP). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
Lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial (RSV), influenza A and influenza B viral nucleoprotein antigens in nasal swabs as an aid in diagnosis of symptomatic individuals. Intended for use at the point of care by trained health professionals and for self-testing by lay persons.