FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal
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), specifically the Center for Drug Evaluation and Research (CDER), is soliciting quotations for BioProfile FLEX2 Parts and Components (brand name or equal). This combined synopsis/solicitation aims to award a Firm Fixed-Price (FFP) Purchase Order to procure operational parts and consumables for three currently owned Nova BioProfile Flex 2 instruments. Proposals are due by June 26, 2026, at 12:00 PM Eastern Time.
Purpose & Scope
CDER requires these parts and consumables to maintain the operational readiness of its Nova BioProfile Flex 2 instruments, which are critical for automated bioanalysis in upstream biomanufacturing research. The scope includes providing a list of specific parts and consumables, such as MicroSensor Cards, Reference Sensors, Calibrator Cartridges, and various kits, compatible with the specified instruments.
Key Requirements
- Compatibility: All items must be fully compatible with and functional in the Nova BioProfile Flex 2 instruments (Serial Numbers: T262230070C, T26817050C, T26A200050C) without modification.
- Quality: Items must be new, unused, and free from defects. Grey market and refurbished products are unacceptable.
- Shelf Life: Items must arrive with at least 75% to 80% of their total shelf life remaining.
- Shipping: Items requiring refrigeration or classified as flammable must be shipped according to manufacturer specifications and applicable DOT/IATA regulations. The vendor is responsible for shipping and handling costs and must coordinate with the COR, providing tracking numbers.
- Authorization: Offerors must be the manufacturer or an authorized reseller of the quoted items.
Contract Details
- Contract Type: Firm Fixed-Price (FFP) Purchase Order.
- NAICS Code: 334516 (Laboratory Equipment And Supplies).
- Set-Aside: Unrestricted, full and open competition.
- Period of Performance: 12 consecutive months commencing upon award, with deliveries phased over approximately 300 days post-award.
- Place of Performance: FDA facility, 10903 New Hampshire Ave, Bldg. 52/72 RM 2232, Silver Spring, MD 20903.
Submission & Evaluation
- Inquiries Due: June 22, 2026.
- Proposal Due: June 26, 2026, by 12:00 PM Eastern Time.
- Submission: Electronically to brandon.rafus@fda.hhs.gov. Proposals must be MS Office compatible, without macros or password protection.
- Evaluation: Award will be made on a Lowest Price Technically Acceptable (LPTA) basis, with technical acceptability determined on a pass/fail basis against salient characteristics and minimum requirements.
Contact
For submissions and inquiries, contact Brandon Rafus at brandon.rafus@fda.hhs.gov.