Device Category Dossier

CT826 - Constitutional chromosomal disorder IVDs

Device Category Dossier for CT826 - Constitutional chromosomal disorder IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Constitutional chromosomal disorder in vitro diagnostic devices use fluorescent in-situ hybridization to diagnose, monitor, or predict the presence of chromosomal abnormalities present in all cells of the body. These products are used as adjunct with other tests and not as stand-alone.