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

Project ID: CDER-2026-133117 FederalOpportunitiesSynopsis Solicitation

Overview

Agency	Food and Drug Administration
Deadline	06/26/26
Posted	06/16/26
Estimated Value	$40,000 - $120,000 (AI estimate)
Set Aside	None
NAICS	334516 - Analytical Laboratory Instrument Manufacturing
PSC	6640 - Laboratory Equipment And Supplies
Location	Silver Spring, MD United States

Description

Primary Latest Change

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

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.

Summary (Newest Update)

Background The Center for Drug Evaluation and Research (CDER) of the FDA requires operational parts and consumables for three currently owned Nova BioProfile Flex 2 instruments. The goal of this contract is to ensure that these instruments remain functional and capable of performing automated bioanalysis for cell culture monitoring, which includes measuring parameters such as pH, dissolved gases, metabolites, osmolality, and cell density. The contractor will provide parts that are compatible with the existing instruments to maintain their operational capabilities. Work Details The contractor shall supply the following parts and components compatible with the Nova BioProfile Flex 2 instruments: 1. 10 units of 57510 BioProfile FLEX 2 pH/Gas MicroSensor™ Card LV (125 samples or 21 days) 2. 10 units of 57512 BioProfile FLEX 2 Chemistry MicroSensor™ Card LV (150 samples or 21 days) 3. 1 unit of 57467 BioProfile FLEX 2 pH/Gas Reference Sensor 4. 1 unit of 57466 BioProfile FLEX 2 Chemistry Reference Sensor 5. 8 units of 58102 BioProfile FLEX 2 pH/Gas Calibrator Cartridge MV. All items must be new, unused, free from defects, and delivered with at least 75% to 80% shelf life remaining. Items requiring refrigeration or classified as flammable must be shipped according to manufacturer specifications and applicable regulations. Period of Performance 12 consecutive months commencing upon date of Award. Place of Performance Food and Drug Administration, Attn: Erica Berilla, 10903 New Hampshire Ave, Bldg. 52/72 RM 2232, Silver Spring, MD 20903. Bidder Requirements Offerors must be either the manufacturer or an authorized reseller of the quoted items. All parts must be fully compatible with the Nova BioProfile FLEX 2 instruments without modification. Incumbent Analysis (see Incumbents section for more detail) This opportunity appears to have a confirmed incumbent based on prior contract 75F40120P00236, awarded to Nova Biomedical for operational parts and components for the BioProfile FLEX 2. The prior award value was $236,976 (07/14/20–01/31/24), and the described work aligns with supplying FLEX 2 parts and consumables intended to keep the FDA’s BioProfile FLEX 2 instruments functional. The current RFQ similarly focuses on providing compatible BioProfile FLEX 2 parts/components (e.g., sensor cards, reference sensors, and calibrators) for the agency’s currently owned instruments, suggesting continuity of the same replenishment/maintenance supply requirement.

Contacts