Device Dossier
Constitutional chromosomal disorder IVDs
Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor BGI Health (AU) Company).…
- GMDN category: CT826 - Constitutional chromosomal disorder IVDs
Intended purpose
An IVD kit used to perform prenatal screening for trisomies of chromosomes 21, 18 and 13 (T21, T18 and T13) by analyzing the differences in the number of chromosomes 21, 18 and 13 in the cell-free fetal DNA in maternal plasma samples. This kit is used to prepare a sequencing DNA library of cell free DNA.