Device Dossier
Influenza virus IVDs
Device Dossier for Influenza virus IVDs (CT732 - Influenza virus IVDs, Class 3, sponsor Epic Medical & Health). ARTG record, intended purpose, GMDN…
- GMDN category: CT732 - Influenza virus IVDs
Intended purpose
The Rapid Influenza A/ B RNA Test is a qualitative in vitro nucleic acid RT- LAMP test for the detection of influenza A virus and/or influenza B virus in oropharyngeal swab from individuals suspected of influenza. The test is intended for use by medical professionals, trained operators and clinical laboratory technicians (POCT) The Rapid Influenza A/ B RNA Test is required to be used in combination with Gene Scoper (HG-I202/HG-I204) made by same manufacturer.