The Navy Medical Readiness Logistics Command Detachment Fort Detrick has a requirement for the Drug Demand Reduction Program, for the initial (screen) immunoassay for the detection of 6-Acetylmorphine... The Navy Medical Readiness Logistics Command Detachment Fort Detrick has a requirement for the Drug Demand Reduction Program, for the initial (screen) immunoassay for the detection of 6-Acetylmorphine Immunoassay Reagent Kits in urine > 10 ng mL. Description The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented 6-acetylmorphine Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting 6-acetylmorphine in human urine samples. Proposals shall comply with the Statement of Work (SOW). The reagent kits are required for a period of performance (PoP) of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month. Only Original Equipment Manufacturer (OEM) of reagents, authorized dealer, authorized distributor or authorized reseller for the proposed reagents, such that OEM parameters, quality controls and services are provided and maintained by the OEM, will be considered. All storage, shelf-life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions, as specified in the SOW. The OEM-s reagent product shall not be repackaged by the Offeror unless authorized, as specified in the SOW. The vendor shall comply with the FDA and Quality Management Documentation, as specified in the SOW. The vendor shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW. 1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of 6-acetylmorphine (6AM) in urine when present at a concentration equal to or greater than 10 ng mL The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers (hereafter referred to as “analyzer”) in use at the Department of Defense (DOD) Forensic Toxic... DEPT OF DEFENSE | DEPT OF THE NAVY PHILADELPHIA 700 ROBBINS AVENUE, PHILADELPHIA , PA 19111-5098, USA Primary Point of Contact: JENA VISCONTO, JENA.VISCONTO@NAVY.MIL, Phone Number PHONE (215)697-2910, Fax Number FAX (215)697-3746 james.berghaier@navy.mil Tender Notice International Competitive Bidding N0018924RZ162 United States of America GT-108717163