HLA class I & II antibody screening IVD, kit, multiplex

HLA class I & II antibody screening IVDs are in vitro diagnostic kits designed to detect antibodies against human leukocyte antigens (HLA) in patient samples. Clinically, these devices help assess compatibility for organ transplants, reduce transplant rejection risks, and guide treatment decisions in conditions like autoimmune diseases or blood transfusions.

These kits are typically regulated as IVDs and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are usually supplied as multiplex assays, combining multiple antigens for simultaneous testing, and are intended for use in specialized laboratory settings by trained personnel.