Today, we are proud to announce that ZytoVision, our sister company, received the IVDR certification!
The AmoyDx® Myeloid Blood Cancer Panel enables a comprehensive molecular genetic analysis for the qualitative detection of SNVs, InDels and fusions in 55 genes associated with myeloid leukemia on DNA and RNA.
The IVDR, in force since May 26, 2022, represents a turning point in the EU-wide harmonization of patient safety. At the same time, it places high demands on us as manufacturers and on you as a user of in vitro diagnostic medical devices to implement the new regulation. We would like to meet this challenge together with you for the benefit of your patients. It is important to us to certify our portfolio of diagnostic solutions in compliance with the IVDR in due time. Therefore, we would like to keep you informed about our progress with the implementation of the IVDR.