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

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CDER-2026-133117Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The contract solicitation seeks quotations for supplying parts and components compatible with three Nova BioProfile FLEX 2 instruments owned by the FDA’s Center for Drug Evaluation and Research (CDER). The requirement includes parts for two main FLEX2 instruments and an additional external sampling module, each identified by specific serial numbers. The contractor must provide new, unused, and defect-free commercial parts or equivalent consumables that fully function with the instruments in their current configuration, without requiring modifications. Delivered items must maintain at least 75% to 80% of their shelf life, and those requiring special conditions such as refrigeration or flammable item handling must comply with relevant regulations. Only manufacturers or authorized resellers may submit quotes, which are due via email by June 26, 2026. The contract period covers 12 consecutive months from the award date, with performance based at the FDA facility in Silver Spring, Maryland. The procurement process is issued as a combined synopsis/solicitation under commercial item acquisition rules, with no separate solicitation document forthcoming. The solicitation emphasizes strict adherence to delivery schedules and quality standards detailed in the attached Statement of Work. Communication and submission of quotations are managed through the designated FDA point of contact.

General Info

Supply new, compatible parts for three Nova BioProfile FLEX 2 instruments; delivery by June 26, 2026.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

334516 - Analytical Laboratory Instrument Manufacturing View NAICS

Place of Performance

Silver Spring, MD, USA

Set-Aside

NONE

Documents

(2)

Combined+Synopsis+Solicitation-+CDER-2026-133117-+Final+-+SAM+Posting+06.16.2026.pdf

PDF

SOW-CDER-2026-133117-SAM+Posting.pdf

PDF

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Timeline

PhaseCombined Synopsis
Posted

Combined Synopsis

Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeRockville, MD, 20852, USA
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
Office AddressRockville, MD, 20852, USA
Contacts
Brandon Rafus
contact@example.gov

Full Description

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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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