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budfoxfun

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budfoxfun

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Wednesday, 06/01/2022 11:12:12 AM

Wednesday, June 01, 2022 11:12:12 AM

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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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