Device Dossier

Interpretive software IVDs

Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 2, sponsor Immuno). ARTG record, intended purpose, GMDN category…

Intended purpose

IVD software for qualitative analysis, meant for clinical laboratory professional users, for the identification of bacteria, fungi and yeasts of isolates from positive cultures of biological samples which may then be used to guide patient management.

TGA Public Summary