EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.1 The EUA Submission for the FloodLAMP EasyPCR COVID-19 Test v1.1 describes an extraction-free, duplex RT-qPCR assay using CDC N1 and RNaseP targets after chemical plus heat inactivation, designed for CLIA high-complexity labs running routine screening programs (e.g., schools and workplaces) with at least weekly testing. It details intended use, validated instruments, workflow, controls, and component sourcing for an open-protocol deployment. It summarizes performance claims including a 3,100 copies/mL LoD and 97.5% positive agreement with 100% negative agreement in an 80-specimen clinical evaluation. primary file regulatory fl-fda-submissions 2021-05-18_EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.1.md regulatory/fl-fda-submissions/2021-05-18_EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.1.md 2021_05_18 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 5489 8979 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