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May 30, 2020  •  Blog

New Policy for SARS–CoV–2 Serology Tests

FDA significantly tightened oversight on SARS‐COV‐2 serology tests by publishing new policy requiring all serology tests to be reviewed and approved under Emergency Use Authorization (EUA). In a rush to make serology antibody tests available as quickly as possible, FDA previously allowed SARSCOV‐ 2…

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