EUROIMMUN anti-SARS-CoV-2 S1 curve ELISA received FDA Emergency Use Authorization

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On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization (EUA) for its Anti-SARS-CoV-2 S1 CurveTM ELISA (IgG). This assay allowed for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma.

Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were able to immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

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Source: NASDAQ
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