Description
The Department of the Navy is seeking a contractor to provide Fentanyl/Norfentanyl Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting fentanyl/norfentanyl in human urine samples. The contractor shall provide FDA and Quality Management documented reagent kits. The period of performance is from 01 August 2026 to 31 July 2031.
Some key features of the contract include:
* The reagent kits must be compatible with the Beckman Coulter AU5800 series systems.
* The contractor must provide documentation of FDA approval/authorization for use of the Fentanyl Immunoassay Reagent.
* The contractor must provide documentation of current certification compliance with applicable ISO Standards or documentation of compliance with the Statement of Work.
* The contractor must provide a statement of work compliance attestation and OEM requirements.
* The contractor must provide reagent preparation and calibration information.