Device Dossier
Human genetics-related IVDs
Device Dossier for Human genetics-related IVDs (CT906 - Human genetics-related IVDs, Class 3, sponsor Aim Discovery Solutions). ARTG record, intended…
- GMDN category: CT906 - Human genetics-related IVDs
Intended purpose
The FastQ® B*27 kit is a manual genetic test performed to determine the presence or absence of HLA-B*27 alleles that are associated with different types of axial spondyloarthritis and indicate a more severe course of the disease.