Device Dossier
Constitutional chromosomal disorder IVDs
Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor Carl Zeiss). ARTG record,…
- GMDN category: CT826 - Constitutional chromosomal disorder IVDs
Intended purpose
IVDs that are intended to be used for fluorescent in-situ hybridization (FISH) for diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature, i.e. present in all cells of the body (CT826 Constitutional chromosomal disorder IVDs) . These products are to be used as adjunct with other tests and not as stand-alone.