Device Dossier
Multiple-viruses IVDs
Device Dossier for Multiple-viruses IVDs (CT702 - Multiple-viruses IVDs, Class 3, sponsor Abacus dx). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT702 - Multiple-viruses IVDs
Intended purpose
STANDARD M10 Flu/RSV/SARS-CoV-2 test is a multiplex real-time RT-PCR test intended for use with STANDARD M10 system for aiding in the qualitative detection of Influenza A, Influenza B, RSV and SARS-CoV-2 nucleic acids in human nasopharyngeal swab collected from individuals suspected of a respiratory disease by their healthcare provider. The test is intended to be performed by trained users in both laboratory and point of care testing setting.