EUA and 510(k) clearance of SARS-CoV-2 Antigen Diagnostic Test
Award Notice Posted
- Solicitation number
- 75A50121P00026
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Awarded
- to Mbio Diagnostics Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50121P00026 Federal contract award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Boulder CO 80303 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This Award Notice from the Department of Health and Human Services announces a contract awarded to MBIO Diagnostics, Inc. on February 3, 2021 for $5,654,478. The contract facilitates obtaining FDA emergency use authorization and 510(k) clearance for a SARS-CoV-2 antigen diagnostic test to support COVID-19 recovery efforts. The award was made under a class justification and approval that allows for immediate acquisition of supplies and services valued at up to $30 billion to address urgent pandemic needs through March 2021, as authorized by a national emergency declaration on March 13, 2020.
Notice text
This contract action was awarded under a class Justification & Approval (J&A) in accordance with FAR 6.302-2, Unusual and Compelling Urgency, to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19). This class J&A is essential to respond to urgent requests for immediate support to respond to the expanding outbreak of COVID-19 which was declared a global pandemic by the World Health Organization (WHO) on March 11, 2020 and a national emergency via a Presidential Proclamation on March 13, 2020.
The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time and current data indicate that COVID-19 has begun to spread exponentially, in the typical pattern for an epidemic. This constitutes an unusual and compelling urgency that demands immediate attention. Immediate acquisition of services and supplies will help ensure that the United States of America remains prepared for and capable of responding to a public health emergency in the necessary and immediate manner that is required.
Awarded contract 75A50121P00026 to MBIO DIAGNOSTICS, INC. for 5654478.00 on 2021-02-03.
Files
| File | Type | Posted |
|---|---|---|
| Class J and A Final 3.21.20.pdf |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity