Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Stonestar Wholesale). ARTG record, intended purpose, GMDN…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
The test kit is intended for simultaneous qualitative detection and differentiation of SARS CoV 2, Influenza A virus and Influenza B virus RNA from nasopharyngeal (NP) nasal sw ab specimens or BALF collected in transport medium by a healthcare provider (HCP)from individuals suspected of respiratory viral infection consistent with COVID 19.