Human genetics-related IVDs

Intended purpose

An IVD intended for qualitative and semi-quantitative device for discrimination, relative quantification and monitoring to perform various human genetics-related tests and procedures (e.g mixed chimerism using genomic DNA (gDNA) from peripheral blood or bone marrow from patients following hematopoietic stem cell transplantation (HSCT), donor-derived cell-free DNA (dd cfDNA) in plasma from patients following kidney Transplantation). The procedure is manual and is intended to be used by qualified laboratory professionals only.