January 2025—Qiagen announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE marking under the European Union in vitro diagnostic medical devices regulation. The certification includes the QIAstat-Dx analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The submission for IVDR certification of the QIAstat-Dx meningitis/encephalitis panel is expected in the coming months. The company is transitioning more than 180 products to the IVDR framework.
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