Bio-Techne announced that it has received In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators.
The certification confirms that the products comply with the regulations and guidelines set forth by the European Union for IVD devices.
The Bio-Techne R&D Systems Hematology Controls and Calibrators have received class B certification under IVDR, which covers devices and tests that may pose a moderate to low personal risk and low public health risk. Hematology controls and calibrators are essential components that support accuracy in patient testing in laboratories, Bio-Techne said in a statement. Receiving the IVDR certification "marks an important milestone in Bio-Techne's commitment to meeting the needs of healthcare professionals," the firm added.
