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68 -- Vidas Test Kits

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Reference-Number-1005574Federal

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The Food and Drug Administration plans to award a sole source purchase order to BioMerieux Vitek, Inc., based in Durham, North Carolina, for Vidas Test kits and reagents. BioMerieux Vitek is uniquely positioned as the sole manufacturer and distributor of these kits, which are the only ones approved under CDC protocols for detecting microbial phenotypes within select agent registration methods. The contract highlights the critical need for consistent and approved testing methods that align with CDC standards across all U.S. laboratories, ensuring uniformity and rapid response in microbial detection. The acquisition will proceed under established federal regulations governing commercial item purchases and simplified acquisition procedures. Although not a request for competitive bids, the FDA encourages potential sources to submit detailed documentation of their capabilities, which may influence future competition decisions. The award decision is expected within ten days from the notice date, underscoring the urgency and importance of securing these specialized testing kits for ongoing public health efforts.

General Info

FDA awards sole source contract to BioMerieux Vitek for CDC-approved microbial test kits.

Agency

N/A

NAICS

339999 - All Other Miscellaneous Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Timeline

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Organization & Contact Information

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AgencyN/A
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Office AddressN/A
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Full Description

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The Food and Drug Administration intends to award a purchase order on a sole source basis to BioMerieux Vitek, Inc., 100 Roldolphe Street, Durham, NC 27712-9402. BioMerieux Vitas, Inc. is the sole manufacturer and distributor of Vidas Test kits and reagents. No other such kits or reagents have been approved for the CDC protocols under the select agent registration for methods used for detection capabilities. The methods used in the detection program can only be conducted using known and proven methods that have been approved by CDC for all labs in the US to measure and detect microbial phenotypes. The BioMerieux Vitek kits provide uniformity with the de facto international standard for research and rapid response. FDA intends to make an award ten (10) days from the date of this notice. This is not a request for quotes; however, sources may submit descriptive literature, fully documenting their capabilities, which will be considered by the agency. A determination to compete this procurement based on response(s) to this notice is solely within the description of the Government. This award will be made in accordance with FAR Part 12, Acquisition of Commercial Items, and FAR Part 13, Simplified Acquisition Procedures.

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