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…

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.

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