Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Compliance Management Solutions). ARTG record, intended…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, RSV and Adenovirus antigens in self-collected nasal swab specimens as an aid in the diagnosis of SARS-CoV-2, Influenza A/Influenza B, RSV and Adenovirus infection. The test is intended for individuals who are suspected of being infected with SARS-CoV-2 within 7 days of symptom onset and/or Influenza A+B, RSV and Adenovirus within the first 4 days of symptom onset.For self-testing in vitro diagnostic use.