FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal
Closed Solicitation Posted
- Solicitation number
- CDER-2026-133117
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Silver Spring, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Center for Drug Evaluation and Research seeks a single contractor to supply operational parts and consumables for three Nova BioProfile FLEX 2 instruments, with proposals due June 26, 2026 and questions due June 22 at 12:00 PM EDT. This is an unrestricted, full and open competition with no set-aside.
Place of performance is Silver Spring, Maryland, specifically CDER's Advanced Manufacturing Research Facility (Building 52/72 RM 2232). The procurement requires the contractor to be either the manufacturer or an authorized reseller; if not the manufacturer, OEM-certified service is mandatory. All quoted items must be new, unused, and free from defects with 75–80% of total shelf life remaining upon delivery; grey market and refurbished products are unacceptable. Contractor must provide at least one year extended warranty covering defects in workmanship and component failure.
Deliverables span four phased delivery windows: within 7 days of award, 90–120 days post-award, 180–210 days post-award, and 270–300 days post-award. Phase 1 comprises 25 line items including pH/gas MicroSensor cards, chemistry MicroSensor cards, calibrators, reagent cartridges, reference solutions, and cleaning solutions in specified quantities. Subsequent phases contain similar consumable replenishment items. All items within a designated phase must be provided in full or none at all; failure to deliver all supplies within a phase triggers liquidated damages. Pricing must be all-inclusive of shipping, handling, and applicable fees, with firm pricing for one year post-award. Award will be made on a Firm Fixed-Price basis to the lowest-priced technically acceptable offeror (LPTA evaluation). The NAICS code is 334516, Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1,000 employees.
Notice text
Request for Quotation: FDA-RFQ-CDER-2026-133117 BioProfile FLEX2 Parts and Components-Brand Name or Equal
Notice of Combined Synopsis/Solicitation – This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.
Background – The Center for Drug Evaluation and Research (CDER) requires operational parts and consumables for three (3) currently owned Nova BioProfile Flex 2 instruments. To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components listed in the Statement of Work (SOW) that must be compatible with the corresponding three (3) NOVA BioProfile Flex 2 instruments:
Main FLEX2 instrument 1: Serial Number- T262230070C
Main FLEX2 instrument 2: Serial Number- T26817050C
External sampling module for instrument 2: T2761720PC
Main FLEX2 instrument 3: Serial Number- T26A200050C
Please note Main FLEX2 instrument 2 has two serial numbers because it has an additional module added which has its own Serial Number. The offeror is also expected to adhere to the:
the established delivery times as expressed in Section 5.1 of the attached combined solicitation/synopsis the fullest extent practicable.
Minimum Salient Characteristic Requirements:
1. Compatibility is needed for three currently owned Nova BioProfile Flex 2 instruments as described in this Section (Section 5). The Contractor shall identify the following salient characteristics for BioProfile Flex-2 commercial parts and consumables or equal
2. Instrument identity: Manufacturer (Nova Biomedical), instrument name and model (BioProfile FLEX 2), and all three serial numbers of the government-owned instruments
3. Instrument function: Automated bioanalysis system for cell culture monitoring, measuring parameters such as pH, dissolved gases, metabolites, osmolality, and cell density
4. Compatibility requirement: All parts and consumables supplied must be fully compatible with and functional in the Nova BioProfile FLEX 2 as configured at the FDA facility, without modification to the instrument
5. Quality standard: All items must be new, unused, and free from defects; grey market and refurbished products are unacceptable
6. Shelf life: All items must arrive with at least 75% to 80% of their total shelf life remaining upon delivery
7. Cold chain: Items requiring refrigeration or classified as flammable must be shipped and delivered in accordance with manufacturer specifications and applicable DOT/IATA regulations
8. Authorization: Offeror must be the manufacturer or an authorized reseller of the items quoted
Place of Performance:
Food and Drug Administration
Attn: Erica Berilla
10903 New Hampshire Ave
Bldg. 52/72 RM 2232
Silver Spring, MD 20903
Period of Performance:
12 consecutive months commencing upon date of Award.
Please see the attached Statement of Work and Corresponding Justification for reference/utilization. Quotes are due by email on or before June 26, 2025, by 12:00 P.M. (Eastern Daylight Time) and should be sent to brandon.rafus@fda.hhs.gov.
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