Notice of Intent- Biomerux.pdf

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Notice of Intent to Sole Source- BioMerieux
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This is a Notice of Intent for a sole source contract award. The Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) intends to award a sole source contract to bioMérieux, Inc. (100 Rodolphe Street, Durham, NC 27712) for annual preventive maintenance and calibration services on proprietary laboratory equipment. The equipment requiring service includes VITEK C 0015 (1 unit), VITEK C 0030 (1 unit), Vitek C 0060 (7 units), Vitek MS PLUS (2 units), APS ONE (1 unit), MYLA (2 units), and PREVI COLOR V2 (1 unit). Services will be performed across seven ORTS laboratories located in Arkansas, Colorado, New York, California (two locations), Washington, and Georgia.

The contract will consist of a 12-month base period followed by four optional 12-month renewal years. All services must be performed in accordance with ISO 17025 standards by Original Equipment Manufacturer (OEM) certified technicians using only OEM parts. The justification for sole source selection is based on the proprietary nature of bioMérieux VITEK instruments, which require specialized software, diagnostic tools, and OEM-certified expertise available exclusively through the manufacturer or authorized representatives. Use of non-OEM parts or unauthorized technicians would void warranties and compromise ISO 17025 accreditation essential for FSIS regulatory testing. Although this is not a formal Request for Quote, responsible sources may submit capability statements demonstrating OEM-authorized dealer, distributor, or reseller status, including company identification (Name, Address, CAGE Code, UEI), evidence of OEM authorization to service TEMPO and Media Prep systems, and confirmation of ability to provide OEM-certified technicians and parts. All submissions must be emailed to the Contracting Officer/Specialist, and the Government reserves the right to determine whether to compete this requirement based on responses received.

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Notice of Intent #FDA-RFQ-26-132839

The Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) intends to award a sole source contract to bioMérieux, Inc. (100 Rodolphe Street, Durham, NC 27712) for annual preventive maintenance (PM) and calibration of:

• VITEK C 0015 (1)

• VITEK C 0030 (1)

• Vitek C 0060 (7)

• Vitek MS PLUS (2)

• APS ONE (1)

• MYLA (2)

• PREVI COLOR V2 (1)

Services shall be performed at the following ORTS Laboratories:

• Arkansas Human and Animal Food Laboratory (ARHAFL)- Jefferson, AR 72079-9502

• Denver Human and Animal Food Laboratory (DENHAFL) -Denver, CO 80225-0087

• New York Human and Animal Food Laboratory (NYHAFL) -Jamaica, NY 11433-1034

• Irvine Human and Animal Food Laboratory (IRVHAFL)- Irvine, CA 92612-2506

• Seattle Human and Animal Food Laboratory (SEAHAFL)- Bothell, WA 98021-4421

• San Francisco Human and Animal Food Laboratory (SANHAFL)- Alameda, CA 94502

• Atlanta Human and Animal Food Laboratory (ATLHAFL)- Atlanta, GA 30309

The contract will consist of a 12-month base period and four (4) 12-month option years. All services must be performed in accordance with ISO 17025 standards and by Original Equipment Manufacturer (OEM) certified technicians using only OEM parts. The bioMérieux VITEK instruments are proprietary equipment. Maintenance requires specialized software, diagnostic tools, and OEM-certified technical expertise available only through the manufacturer or its authorized representatives. Use of non-OEM parts or unauthorized technicians would void existing warranties and compromise the ISO 17025 accreditation essential for FSIS regulatory testing.

This notice of intent is not a Request for Quote (RFQ). However, responsible sources may submit a capability statement demonstrating their status as an OEM-authorized dealer, distributor, or reseller.

Submissions must include:

• Company Name, Address, CAGE Code, and UEI.

• Evidence of OEM Authorization to service TEMPO and Media Prep systems.

• Confirmation of ability to provide OEM-certified technicians and parts.

All responses must be submitted via email to the Contracting Officer/Specialist. The Government reserves the right to determine whether to compete this requirement based on responses received.

File details come from the government source that posted it. Updated .