Multiple human leukocyte antigens (HLA) typing IVDs

Intended purpose

In-vitro diagnostic kits intended for the amplification of human genomic DNA specimens. The kits are intended to generate HLA amplicons by PCR (Polymerase Chain Reaction) which are suitable for HLA genotyping. The associated library kit is used with the qualitative in vitro diagnostic device and is intended for library preparation for down-stream Next-Generation Sequencing(NGS) applications. The IVDs are intended to be used by laboratory professionals.