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FDA Website - Antigen EUA Revisions for Serial Repeat Testing The Antigen EUA Revisions for Serial Repeat Testing summarizes FDA’s November 1, 2022 revision updating authorized uses and labeling for all authorized SARS-CoV-2 antigen tests to emphasize repeat testing after a negative result. It sets new serial-testing instructions—at least twice over three days for symptomatic use and at least three times over five days for asymptomatic use, with 48 hours between tests—and requires EUA holders to submit supplemental requests with updated labeling. The revision also adds one new Condition of Authorization and removes one that FDA determined was no longer needed. primary file regulatory fda-policy 2022-11-01_FDA Website - Antigen EUA Revisions for Serial Repeat Testing.md regulatory/fda-policy/2022-11-01_FDA Website - Antigen EUA Revisions for Serial Repeat Testing.md 2022_11_01 date converted 2024-04-05 website Public Domain 265 394 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url
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