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 kit is intended for in vitro qualitative detection of SARS-CoV-2, influenza A and influenza B nucleic acid of the oropharyngeal swab samples which of the people who were suspected infection of SARS-CoV-2, influenza A and influenza B. It also can be used in suspected pneumonia and suspected cluster cases and for qualitative detection and identify of SARS-CoV-2, influenza A and influenza B nucleic acid in oropharyngeal swab samples of novel Coronavirus infection in other circumstances.