FDA-RFQ- BioProfile FLEX2 Parts and Components-Brand Name or Equal

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.