Luminex Corporation ARIES SARS-CoV-2 FDA 510(k) Clearance
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 75A50122P00023
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50122P00023 Federal contract award
- Awardee
- Luminex Corp
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Austin, Texas 78727, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research & Development Authority published a Limited/Sole Source Justification Notice to award a firm-fixed price contract valued at $1,981,921 to Luminex Corporation. The purpose of this sole source contract is to fund the necessary clinical evaluations and 510(k) submission to obtain FDA clearance for Luminex's proprietary ARIES Flu A/B/RSV + Coronavirus diagnostic test, allowing for long-term use beyond emergency authorization in response to the COVID-19 pandemic and national emergency.
Notice text
The Government procured the required clinical and development services to obtain U.S. Food and Drug Administration (FDA) Section 510(k) clearance of Luminex Corporation’s combined ARIES ® Flu A/B/RSV + Coronavirus (SARS-CoV-2 test using simplified acquisition procedures. FDA 510(k) clearance will allow Luminex to commercially market their combined SARS-CoV-2, influenza A, influenza B, and Respiratory syncytial virus (RSV) diagnostic test that operate on the proprietary ARIES® platform.
Awarded contract 75A50122P00023 to unknown vendor for unknown amount on 2022-09-21.
Files
| File | Type | Posted |
|---|---|---|
| FAR 13.5_SSJ_Certain Commercial Items Final Approved.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Limited / Sole Source Justification | |
| Luminex Corporation ARIES SARS-CoV-2 FDA 510(k) Clearance | Special Notice |
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