www.fdanews.com/articles/204777-euroimmun-covid-19-antibody-assay-curve-elisa-gets-eua
Euroimmun COVID-19 Antibody Assay Curve Elisa Gets EUA
October 11, 2021
Euroimmun has received Emergency Use Authorization from the FDA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG) assay for detecting COVID-19 infections.
The test, which is both qualitative and semi-quantitative, identifies antibodies formed against the SARS-CoV-2 coronavirus from blood samples.
Clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 can immediately begin using the test, according to Waltham, Mass.-based Euroimmun, a PerkinElmer subsidiary.
The test received a CE mark certification last November.