Device Dossier
Inborn/inherited genetic disorder IVDs
Device Dossier for Inborn/inherited genetic disorder IVDs (CT903 - Inborn/inherited genetic disorder IVDs, Class 3, sponsor Revvity). ARTG record,…
- GMDN category: CT903 - Inborn/inherited genetic disorder IVDs
Intended purpose
IVDs that are intended to be used in genetic testing for diagnosing, monitoring or predicting the presence of monogenic or polygenic disorders that are either inborn or inherited and that are not associated with mitochondrial disease.