Device Dossier

Interpretive software IVDs

Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 3, sponsor Copan). ARTG record, intended purpose, GMDN category…

Intended purpose

Software program with image analysis algorithms for the automatic sorting of media plates to assist the analysis of microbial cultures for the semi-quantitative/qualitative detection of infectious microorganisms and automatic selection of colonies suitable for picking activities. It is intended to be used by trained healthcare professionals and to be installed in Microbiology Laboratory or Hospital Department.

TGA Public Summary