Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor Ortho-Clinical Diagnostics). ARTG record,…

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 viral diseases. The test is intended for professional and laboratory use.

TGA Public Summary