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SAMDAILY.US - ISSUE OF MAY 08, 2021 SAM #7098
SOLICITATION NOTICE

Q -- COVID-19 Laboratory IVD (Diagnostics)

Notice Date
5/6/2021 7:39:50 AM
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
325413 — In-Vitro Diagnostic Substance Manufacturing
 
Contracting Office
OFFICE OF ACQ MGMT POLICY WASHINGTON DC 20201 USA
 
ZIP Code
20201
 
Solicitation Number
75A50121R00037
 
Response Due
5/13/2021 12:00:00 PM
 
Archive Date
05/28/2021
 
Point of Contact
Jeffrey Schmidt, Phone: 202.205.0260
 
E-Mail Address
jeffrey.schmidt2@hhs.gov
(jeffrey.schmidt2@hhs.gov)
 
Small Business Set-Aside
SBA Total Small Business Set-Aside (FAR 19.5)
 
Description
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. The beta.sam.gov posting and the attached CSS was modifed at 10:40AM EDT, May 6, 2021 to remove reference to this being a requirements for a ""Molecular"" diagnostic test.
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/f7ebc5723c964a4eaeb8c8e5d10abe47/view)
 
Record
SN05993704-F 20210508/210506230114 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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