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…
- GMDN category: CT910 - Interpretive software IVDs
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.