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    About EUROIMMUN's product range for COVID-19 diagnostics

EURORealTime SARS-CoV-2 approved by the FDA via an Emergency Use Authorization

08th June 2020

Subsequent to the EUROIMMUN-Anti-SARS-CoV-2 ELISA (IgG), the EURORealTime SARS-CoV-2 for direct pathogen detection has now also been approved for use in authorised laboratories by the U.S. American Food and Drugs Administration (FDA) within the framework of an Emergency Use Authorization (EUA).

Press release

FDA fact sheet for laboratories

FDA fact sheet for patients


12th May 2020

EUROIMMUN UK, a subsidiary of EUROIMMUN AG, is based in London and has supported Public Health England (PHE) in establishing a serology assay for use in the National Testing Strategy since March with tens of thousands of tests delivered. The EUROIMMUN tests are being used in a serosurveillance study, the results of which will inform the UK Government’s strategy to combat the pandemic.

Press release EUROIMMUN UK

Important update to the EUROIMMUN product portfolio for serological diagnostics of COVID-19

06th May 2020

Dear EUROIMMUN customer,
Yesterday, ourAnti-SARS-CoV-2 ELISA (IgG) was approved by the US-American Food and Drug Administration (FDA) by an emergency use authorization(EUA). The results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization. We are delighted that the excellent performance and reliability of our test system was therewith also officially acknowledged in the US.

Customer letter EUROIMMUN AG

FDA Provides Emergency Use Authorization to PerkinElmer for Serological Test to Identify COVID-19 Antibodies

05th May 2020

WALTHAM, Mass.--(BUSINESS WIRE)--May 5, 2020-- PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

Press release PerkinElmer, Inc.