Beckman Coulter Life Sciences (Indianapolis) has received an EU Quality Management System Certificate under the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) for more than 200 flow cytometry reagents manufactured at its Marseille, France facility. In May 2022, IVDR 2017/746 will replace the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been in place…

Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe. Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the…