FDA Website - Press Release FDA Issues EUA for SalivaDirect The FDA press release announces the August 15, 2020 emergency use authorization for Yale School of Public Health’s SalivaDirect SARS-CoV-2 diagnostic test, highlighting saliva-based collection and a workflow that can skip nucleic acid extraction. It explains how the “open source” protocol and validation across multiple common reagents/instruments could expand testing capacity while reducing reliance on scarce swabs and extraction kits. primary file regulatory open-euas 2020-08-15_FDA Website - Press Release FDA Issues EUA for SalivaDirect.md regulatory/open-euas/2020-08-15_FDA Website - Press Release FDA Issues EUA for SalivaDirect.md 2020_08_15 date converted 2025-12-19 webcopy Public Domain 678 884 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