EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.0 The EUA Submission for the FloodLAMP QuickColor COVID-19 Test v1.0 describes an extraction-free, colorimetric RT-LAMP assay for qualitative SARS-CoV-2 detection using a visual pink-to-yellow readout and no specialized instrumentation. It details intended use for weekly screening of symptomatic and asymptomatic individuals, primer design targeting three viral genes, sample inactivation workflow, controls, and interpretation criteria for CLIA high-complexity labs. It reports analytical and clinical performance including a 12,500 copies/mL LoD and 90% positive agreement with 100% negative agreement in an 80-specimen clinical evaluation. primary file regulatory fl-fda-submissions 2021-03-22_EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.0.md regulatory/fl-fda-submissions/2021-03-22_EUA Submission - FloodLAMP QuickColor COVID-19 Test v1.0.md 2021_03_22 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 9039 16270 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