Device Category Dossier

CT1261 - Microbial-isolate identification and testing IVDs

Device Category Dossier for CT1261 - Microbial-isolate identification and testing IVDs. Australian ARTG records, sponsors, device class — compiled by…

Carbapenemase detection kits use colloidal gold immunochromatography for rapid qualitative detection of specific carbapenemase enzymes (KPC, IMP, NDM, VIM, and OXA-48) in bacterial samples obtained after culture. These devices aid the rapid detection of β-lactamase activity towards selected microorganisms subcultured from human specimens and are used in conjunction with other clinical and laboratory findings.