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FloodLAMP Email to Tim Stenzel - 4 pages The FloodLAMP email to FDA CDRH (for Dr. Tim Stenzel) summarizes FloodLAMP’s EUA and pre-EUA history and requests interactive review and prioritization for resubmitted COVID-19 molecular tests (EasyPCR duplex PCR and QuickColor colorimetric LAMP) and a pooled home-collection kit with a mobile app. It highlights reported performance and operational claims (LoDs, turnaround times, high-throughput pooling, low-cost scaling) and describes non-diagnostic surveillance deployments with pooled anterior nares swabs, training approach, and field screening metrics. It also frames an “open protocol”/Right-of-Reference strategy for broader adoption, commercialization, and global tech transfer, and asks for guidance on integrating surveillance programs with EUA-authorized testing and CLIA lab expansion. primary file regulatory fl-fda-correspondence 2021-10-04_FloodLAMP Email to Tim Stenzel - 4 pages.md regulatory/fl-fda-correspondence/2021-10-04_FloodLAMP Email to Tim Stenzel - 4 pages.md 2021_10_04 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 1779 2327 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
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