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 2, sponsor Becton…

Intended purpose

IVDs used for identification and/or susceptibility testing of micro-organisms which may include aerobic and anaerobic gram-positive and negative bacteria, yeast and yeast-like organisms.

TGA Public Summary