Device Dossier

Multiple-bacteria IVDs

Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor AusDiagnostics). ARTG record, intended purpose, GMDN category…

Intended purpose

To detect nucleic acid sequences specific to bacterial pathogens, at least one of which is listed in the Australian NNDSS, in samples derived from human specimens.

TGA Public Summary