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EliTechGroup Gets IVDR Class C Certification for Three PCR-Based Assays

NEW YORK — French molecular diagnostics and reagent company EliTechGroup said last week that it has received European In Vitro Diagnostic Medical Device Regulation (IVDR) Class C certification for three of its PCR-based assays.

The tests receiving the certification include the CMV RNA Elite MGB Kit for the detection of human cytomegalovirus virion mRNA; the Coagulation Elite MGB Kit for the detection and the allelic discrimination of the three main variants associated with thrombosis and embolisms; and the BCR-ABL P210 Elite MGB Kit for the quantification of mRNA of the BCR/ABL oncogene P210 isoform associated with chronic myelogenous leukemia and in acute lymphoid and myeloid leukemia.

Most molecular devices are regulated under Class C of Europe's IVDR. Class C covers in vitro diagnostic devices that represent a medium to high risk to the general population but lesser risk than Class D devices.

EliTechGroup was recently acquired by Bruker for nearly $930 million in cash.