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2022-08-15
IVDR-registration of the Class A products part of QuickMIC
Today we announce that we have registered QuickMIC® instrument and sample preparation kit as IVDR Class A. This implicates that our diagnostic system now fulfills the new regulatory requirements and transition provision for the European market. Following clinical performance evaluation, all devices in the QuickMIC system were CE-IVD marked earlier in 2022, indicating IVDD compliance.