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