SPECIAL NOTICE
A -- Luminex Corporation ARIES SARS-CoV-2 FDA 510(k) Clearance
- Notice Date
- 7/12/2022 10:50:52 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- BARDA - ASPR / DAAPPO / BARDA DCMA WASHINGTON DC 20515 USA
- ZIP Code
- 20515
- Solicitation Number
- BARDA-06362022
- Response Due
- 7/27/2022 11:00:00 AM
- Point of Contact
- Davis Perkins, Amber Gray
- E-Mail Address
-
davis.perkins@hhs.gov, amber.gray@hhs.gov
(davis.perkins@hhs.gov, amber.gray@hhs.gov)
- Description
- This is a notice of intent to sole source to Luminex Corporation for�the required clinical and development work 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.� Interested vendors should contact the POCs listed in this notice prior to July 27, 2022 at 2:00pm Eastern.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/a8a488d4aa2b4376bc6dcad107493eef/view)
- Place of Performance
- Address: Austin, TX 78727, USA
- Zip Code: 78727
- Country: USA
- Zip Code: 78727
- Record
- SN06385323-F 20220714/220712230100 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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