Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Innovation Scientific). ARTG record, intended purpose, GMDN…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The Flu A/B, RSV & COVID-19 Antigen Combo Test Device is a rapid immunoassay for the direct and qualitative detection of SARS-CoV-2, influenza A, influenza B and respiratory syncytial viral antigens from nasal secretions in symptomatic individuals. The test is designed for self-testing use.