BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

March 22, 2024

https://www.prnewswire.com/news-releases/bio-techne-receives-european-ivdr-certification-for-diagnostic-test-to-monitor-chronic-myeloid-leukemia-302096618.html

The QuantideX® qPCR BCR-ABL IS Kit is now compliant with the latest diagnostic regulations in Europe

MINNEAPOLIS, March 22, 2024 /PRNewswire/ — Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne’s Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

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