Device Dossier
Interpretive software IVDs
Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 3, sponsor SpeeDx). ARTG record, intended purpose, GMDN category…
- GMDN category: CT910 - Interpretive software IVDs
Intended purpose
An interpretative software algorithm intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or determine the final results of the assay.