Pre-EUA Sub - FloodLAMP Glass Milk LAMP Test The Pre-EUA Sub - FloodLAMP Glass Milk LAMP Test (Nov 6, 2020) is a Molecular Diagnostic Template submission for laboratory use that defines the intended use, measurand, and workflow for a pooled, colorimetric RT-LAMP SARS-CoV-2 test using chemical inactivation plus “glass milk” silica purification for saliva and anterior nares samples in high-complexity CLIA labs. It compiles key regulatory details, validated reagents and prepared solutions, step-by-step procedures, controls, result interpretation criteria, and early performance data (including LoD) to support an EUA pathway for asymptomatic screening and pooling. primary file regulatory fl-fda-submissions 2020-11-06_Pre-EUA Sub - FloodLAMP Glass Milk LAMP Test.md regulatory/fl-fda-submissions/2020-11-06_Pre-EUA Sub - FloodLAMP Glass Milk LAMP Test.md 2020_11_06 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 2321 4342 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