Device Dossier

Microbial-isolate identification and testing IVDs

Device Dossier for Microbial-isolate identification and testing IVDs (CT1261 - Microbial-isolate identification and testing IVDs, Class 3, sponsor Pale…

Intended purpose

KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of KPC, IMP, NDM, VIM and OXA-48 carbapenemases in bacterial samples obtained after culture.

TGA Public Summary