Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Becton Dickinson). ARTG record, intended purpose, GMDN…
- GMDN category: CT774 - Multiple-bacteria IVDs
- Sponsor: Becton Dickinson
Intended purpose
An in vitro diagnostic real-time PCR test that is intended to be used to provide information about infection with multiple specified bacterial organisms. For example, the detection of carbapenem-non-susceptible bacteria that colonise patients in healthcare settings the BD MAX Check-Points CPO Assay is intended to detect the carbapenemase genes blaKPC, blaNDM, blaVIM/blaIMP and blaOXA-48 that are associated with carbapenem non-susceptibility in gram-negative bacteria.