Agilent companion diagnostic assay pd-l1 ihc 28-8 pharmdx receives european ivdr certification

Santa clara, calif.--(business wire)--agilent technologies inc. (nyse: a) today announced the issuing of a class c companion diagnostic in vitro diagnostic regulation (ivdr) certification for pd-l1 ihc 28-8 pharmdx (code sk005). this cdx assay has previously been ce-ivd–marked for sales in the european union and is now certified in accordance with the new eu regulation for in vitro diagnostic medical devices (ivdr) 1. pd-l1 ihc 28-8 pharmdx is approved for exclusive use with the agilent autosta.
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