Notice of Intent to Sole Source- BioMerieux
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) has issued a Notice of Intent to Sole Source to bioMérieux, Inc. for annual preventive maintenance (PM) and calibration of their VITEK Instruments. This notice is not a Request for Quote (RFQ), but responsible sources may submit capability statements demonstrating their authorization as an OEM dealer, distributor, or reseller. Responses are due by April 13, 2026, at 10am EST.
Scope of Work
The contract requires annual PM and calibration services for various bioMérieux VITEK instruments, including VITEK C 0015, VITEK C 0030, Vitek C 0060, Vitek MS PLUS, APS ONE, MYLA, and PREVI COLOR V2. Services must adhere to ISO 17025 standards and be performed by Original Equipment Manufacturer (OEM) certified technicians using only OEM parts. This includes specialized software, diagnostic tools, and OEM-certified technical expertise. Services will be performed at multiple ORTS Laboratories across the United States, including locations in Arkansas, Colorado, New York, California (Irvine and San Francisco), Washington, and Georgia.
Contract & Timeline
- Type: Notice of Intent for Sole Source (Special Notice)
- Duration: 12-month base period with four (4) 12-month option years
- Set-Aside: None specified (intended sole source)
- Response Due: April 13, 2026, 10am EST
- Published: April 7, 2026
Submission Requirements
Interested and responsible sources must submit a capability statement via email to Nina.Montgomery@fda.hhs.gov. 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.
Additional Notes
The use of non-OEM parts or unauthorized technicians would void existing warranties and compromise ISO 17025 accreditation. The Government reserves the right to determine whether to compete this requirement based on responses received.