COVID-19 Laboratory IVD (Diagnostics, Molecular)


Subject: COVID-19 Laboratory IVD (Diagnostics, Molecular)
Solicitation Number: 75A50121R00037
Notice Type: SOLICIT
NAICS: 325413
Set-Aside: Total Small Business
Notice Published: 05-03-21
Response Due: 05-13-21

Agency: Department of Health and Human Services
Office: OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE
Contact: Jeffrey Schmidt This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (202) 205-0260
Office Address: WASHINGTON, DC 20201


Related Notices:
        05-06-21 SOLICIT

        04-30-21 SOLICIT

        04-30-21 SOLICIT


Click for official SAM (FBO) notice, additional information, and accompanying attachments

The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers. See attached Combined Synopsis/Solicitation (CSS) for complete requirement details.