Due to an error by the company the article incorrectly previously stated the firm received Class C certification. It has been corrected to state that it received Class B certification.
NEW YORK – Bio-Techne announced Monday that its R&D Systems Hematology Controls and Calibrators have received Class C certification under Europe's In Vitro Diagnostic Regulation.
Class B certification under IVDR covers devices and tests that may have a moderate risk to individuals or a low risk to the wider population.
The certification "demonstrates the product's exceptional quality standards, ensuring high levels of accuracy, precision, and reliability," Bio-Techne said in a statement.
The controls and calibrators support accuracy in patient testing, the firm added.
R&D Systems produces more than 45 different products for all major hematology instruments manufactured globally, including instruments from Abbott, Danaher's Beckman Coulter, Siemens Healthineers, and Sysmex, according to Bio-Techne's website.