Beckman Coulter Receives EU In Vitro Certificate for Its Flow Cytometry Reagents
Beckman Coulter Life Sciences has received the EU’s Quality Management System Certificate of compliance with the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for more than 200 of its flow cytometry reagents.
The new EU IVDR, which takes effect in May, impacts all European clinical flow cytometry laboratories. “IVDR 2022 is a marathon — not a sprint — for us as well as clinical laboratories,” said Mario Koksch, general manager of Beckman Coulter’s flow cytometry business unit.
The reagents are manufactured at the company’s Marseille, France, facility.