Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor 2San). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
2San 5 in 1 Self-Test (SARS-CoV-2/FluA/FluB/ADV/RSV) Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test for the qualitative detection of SARS-CoV-2 virus, Influenza A virus, Influenza B virus, Adenovirus and Respiratory syncytial virus in human anterior nasal swab samples from symptomatic individuals. The test kit is designed for use as self-testing.