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(Total Views: 199)
Posted On: 06/02/2022 8:45:00 AM
Post# of 23621
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Posted By: budfoxfun
$MYNZ news alert: BERKELEY, Calif. and MAINZ, Germany, June 01, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has successfully completed the conformity assessment of its internal processes to In Vitro Diagnostic Devices Regulation (IVDR) compliance which becomes mandatory from May 26, 2022. Additionally, the ColoAlert patient kit is now CE marked to the IVDR requirements, a significant milestone and achievement for the company. The new, harmonized IVDR regulatory framework has been established to ensure the safety and performance of in-vitro diagnostic medical devices in the European market. Meeting conformity assessment requirements to IVDR compliance for ColoAlert, Mainz Biomed’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), involves meeting new standards for the CE mark of its stool collection tool.

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