Device Dossier
Influenza virus IVDs
Device Dossier for Influenza virus IVDs (CT732 - Influenza virus IVDs, Class 3, sponsor Ortho-Clinical Diagnostics). ARTG record, intended purpose, GMDN…
- GMDN category: CT732 - Influenza virus IVDs
Intended purpose
Influenza immunoassay IVDs intended to be used for the rapid, qualitative detection of acute influenza virus infection including detection of type A and type B antigens as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. This test is intended for professional and laboratory use.