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FDA Website - Umbrella EUA for Independently Validated Serology Tests The Umbrella EUA for Independently Validated SARS-CoV-2 Serology Tests describes FDA’s April 28, 2020 authorization pathway for antibody tests validated through designated government studies such as NIH/NCI. It explains that no tests were ultimately authorized under this umbrella and that FDA revoked the EUA on July 21, 2020 in favor of issuing individual EUAs with test-specific conditions and broader, more flexible scopes of authorization. primary file regulatory fda-policy 2020-04-28_FDA Website - Umbrella EUA for Independently Validated Serology Tests.md regulatory/fda-policy/2020-04-28_FDA Website - Umbrella EUA for Independently Validated Serology Tests.md 2020_04_28 date converted 2024-04-05 website Public Domain 181 271 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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