Device Dossier
Multiple-bacteria IVDs
Device Dossier for Multiple-bacteria IVDs (CT774 - Multiple-bacteria IVDs, Class 3, sponsor Cepheid Holdings). ARTG record, intended purpose, GMDN…
- GMDN category: CT774 - Multiple-bacteria IVDs
Intended purpose
The Cepheid Xpert Carba-R Assay is a qualitative in vitro diagnostic real-time PCR test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48 and bla IMP gene sequences associated with carbapenem-non-susceptibility.