Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.
South Korean diagnostics firm NGeneBio said on Tuesday that it has received CE-IVD marking for its next-generation sequencing-based human leukocyte antigen (HLA) typing assay.
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