EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.1 The EUA Submission for the FloodLAMP QuickColor™ COVID-19 Test v1.1 describes an extraction-free RT-LAMP, colorimetric assay for qualitative SARS-CoV-2 RNA detection from upper respiratory swab specimens in both symptomatic individuals and routine serial screening programs. It details intended use, primer targets (ORF1ab, N, E), workflow and controls, manufacturing inputs, and analytical/clinical performance data to support an FDA Emergency Use Authorization request. primary file regulatory fl-fda-submissions 2021-05-18_EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.1.md regulatory/fl-fda-submissions/2021-05-18_EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.1.md 2021_05_18 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 9114 16140 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