Active Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES
AI Summary
The FDA is seeking quotes for parts and components for three Nova BioProfile FLEX2 instruments. The contractor must provide compatible, new, and defect-free items, adhering to specific delivery and quality standards. Quotes are due by June 26, 2025, and must be submitted via email. This opportunity falls under FAR Part 13 - Simplified Acquisition Procedures.
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.
FDA-RFQ- BIOPROFILE FLEX2 PARTS AND COMPONENTS-BRAND NAME OR EQUAL is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.
SamSearch Platform
AI-powered intelligence for the right opportunities, the right leads, and the right time.