Pre-EUA Sub - FloodLAMP Pooled Swab Collection DTC The Pre-EUA submission for the FloodLAMP Pooled Swab Collection Kit DTC outlines an unsupervised, direct-to-consumer system for pooling 1–4 dry anterior nasal swabs for SARS-CoV-2 testing at designated CLIA high-complexity laboratories. It describes the kit components, ordering/registration and accessioning workflows (including optional use of the FloodLAMP Mobile App for pooling, identity, and results delivery), and planned usability and stability/rehydration validation for use with authorized molecular tests. It frames intended use for asymptomatic screening programs and specifies reporting, labeling, manufacturing, and recordkeeping expectations for an EUA pathway. primary file regulatory fl-fda-submissions 2021-05-18_Pre-EUA Sub - FloodLAMP Pooled Swab Collection DTC.md regulatory/fl-fda-submissions/2021-05-18_Pre-EUA Sub - FloodLAMP Pooled Swab Collection DTC.md 2021_05_18 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 4093 5817 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