Device Dossier
Constitutional chromosomal disorder IVDs
Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor Sysmex). ARTG record,…
- GMDN category: CT826 - Constitutional chromosomal disorder IVDs
Intended purpose
IVDs that are intended to be used in genetic testing for detecting, quantifying, diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature (i.e. present in all cells of the body).