BioFire Defense COVID-19 Test 510(k) with Sample Expansion Option

Closed Special Notice Posted

Solicitation number
JA-20-04-0310
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
541714 Research and Development in Biotechnology (except Nanobiotechnology)
PSC
AJ53 R&D- General Science/Technology: Life Sciences (Advanced Development)
Place of performance
Salt Lake City UT 84107 USA

Notice details come from SAM.gov. Updated .

Notice text

Research and development aimed at securing FDA 510(k) clearance under the Federal Food, Drug, and Cosmetic Act for BioFire Defense’s COVID-19 test. 

Period of Performance: May 2020 to May 2021.

Optional Item: Research and development aimed at improving BioFire Defense’s COVID-19 test by extending its utility to an additional sample type; the current test is limited to nasopharyngeal samples in storage and transport media. Period of Performance: May 2020 to November 2020.

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