Opportunity Overview
The U.S. Food and Drug Administration is seeking Fourier Transform Infrared Spectrophotometer (FTIR), 75F40126Q00406 for the San Juan Medical Products Laboratory in Puerto Rico. The requirement replaces an approximately 17-year-old FTIR system used for routine medical-product sample identification.
Deadline
Quotes are due September 22, 2026 at 3:00 PM Eastern Daylight Time. Questions are due September 18, 2026 at 3:00 PM Eastern Daylight Time.
Scope
The contractor must provide one fully functional modern FTIR system with controller software, onsite installation, hardware and software IQ/OQ, performance verification, calibration and qualification documentation, startup supplies and accessories, inside delivery, and familiarization training for 3 to 5 users. The system must support the laboratory’s stated cGMP/cGLP, ISO/IEC 17025, ISO 9001, and 21 CFR Part 11 requirements and meet the solicitation’s minimum optical, detector, ATR, software, connectivity, warranty, service, and support specifications.
Equipment must be newly manufactured, not used, refurbished, or previously demonstrated. Installation and service must be performed by appropriately factory-trained or certified personnel, with OEM-quality parts and support. Delivery, installation, qualification documentation, training, and manuals are generally required within 6 to 8 weeks after award.
Competition and Classification
This is a full and open, open-market RFQ under NAICS 334516, Analytical Laboratory Instrument Manufacturing, and PSC 6640, Laboratory Equipment and Supplies. The applicable NAICS size standard is 1,000 employees.
Funding / Contract Value
No fixed maximum contract value is stated in the public notice.
Qualification Guidance
Potential respondents should be able to document technical compliance with all minimum FTIR specifications, OEM-qualified installation and service capability, required warranties, validation and qualification support, delivery to Puerto Rico, and all quotation instructions in the current RFQ and any amendments.