www.fdanews.com/articles/199984-beckman-coulter-earns-ce-mark-for-covid-19-antibody-test
Beckman Coulter Earns CE Mark for COVID-19 Antibody Test
November 12, 2020
Beckman Coulter’s Access SARS-CoV-2 immunoglobulin M (IgM) diagnostic test has been granted CE mark certification.
IgM is usually the first antibody to appear during coronavirus infections, so the test can be used to identify infections in individuals that exhibit no symptoms.
The antibody assay is run on the company’s immunoassay analyzers, including its DxI 800 high-throughput system that can process 200 samples per hour.