Device Dossier

Constitutional chromosomal disorder IVDs

Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor Revvity). ARTG record,…

Intended purpose

CT826 Constitutional chromosomal disorder IVDs IVDs that are intended to be used in genetic testing for diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature (ie. present in all cells of the body).

TGA Public Summary