Device Dossier
Interpretive software IVDs
Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 2, sponsor Abacus dx). ARTG record, intended purpose, GMDN…
- GMDN category: CT910 - Interpretive software IVDs
Intended purpose
Software that is intended for generation of data, interpretation, storage, display and/or reporting of results obtained from a clinical laboratory specimen