Opportunity Overview
The U.S. Food and Drug Administration is soliciting Steritest Symbio ISL 2 System Pump, Brand Name or Equal, FDA-RFQ-OC-2026-134494 for the National Forensic Chemistry Center in Cincinnati, Ohio.
Deadline
Quotes are due September 22, 2026 at 4:00 PM Eastern Daylight Time. The live SAM.gov response date is controlling. A deadline sentence in the solicitation text carries an apparent 2025 year typo, while the current posted opportunity is dated and due in 2026.
Scope
FDA requires one newly manufactured Steritest Symbio ISL 2 Med US system or an evaluated equivalent compatible with the existing Getinge ISO-FLEX-R isolator. The system supports sterility testing of parenteral solutions, bags, ampoules, vials, pre-filled syringes, lyophilized products, antibiotics, medical devices, and difficult-to-dissolve powders for forensic and regulatory testing.
Minimum requirements include compatible hardware and accessories, stainless-steel pump housing compatible with vaporized-hydrogen-peroxide decontamination, fit with the existing isolator cutout, a minimum one-year warranty covering parts, labor, travel and support, onsite installation, training for up to three users, and ongoing technical support.
Competition and Classification
This is a brand-name-or-equal requirement with no set-aside listed. NAICS is 334516, Analytical Laboratory Instrument Manufacturing, and PSC is 6640, Laboratory Equipment and Supplies.
Funding / Contract Value
No fixed maximum contract value is stated in the public notice.
Qualification Guidance
Potential respondents should confirm complete compatibility with the existing Getinge ISO-FLEX-R isolator, all minimum pump and accessory requirements, new-equipment status, warranty and service coverage, onsite installation and training, technical support, and all quotation instructions in the current federal package.