Device Dossier
Bacterial infectious disease IVDs
Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Ortho-Clinical Diagnostics). ARTG…
- GMDN category: CT353 - Bacterial infectious disease IVDs
Intended purpose
Immunoassay IVDs intended to be used for rapid, qualitative detection to provide information about infection with or exposure to one or a number of bacterial diseases. The test is intended for professional and laboratory use.