SAM #N0018926RB011

Military Drug Testing: Fentanyl/Norfentanyl Immunoassay Reagent Kits for Beckman Coulter AU5800

This opportunity seeks FDA-cleared Fentanyl/Norfentanyl Immunoassay Reagent Kits for military drug testing programs: - Government Buyer: - U.S. Navy, NAVSUP Fleet Logistics Center Norfolk (Contracting Office, Code 301) - Department of War, Drug Demand Reduction Program - OEMs and Vendors: - Beckman Coulter (OEM, due to required compatibility with AU5800 analyzers) - Only OEMs or authorized distributors with full OEM quality controls and documentation are eligible - Products/Services Requested: - Fentanyl/Norfentanyl Immunoassay Reagent Kits - Must be FDA-cleared and ISO certified - Compatible with Beckman Coulter AU5800 series analyzers - Capable of detecting fentanyl and norfentanyl in human urine samples - Shelf life: minimum 180 days unopened, 14 days opened - Packaging must include thermal protection and instruction sheets with performance data - Estimated quantity: up to 30 million kits over five years (up to 500,000 tests per month) - Unique/Notable Requirements: - Strict sensitivity, specificity, and quality standards - Only OEMs or authorized distributors with full OEM documentation - Reagents must be suitable for forensic toxicology drug testing laboratories - Evaluation includes performance tests, past performance, and small business participation - Places of Performance/Delivery: - Navy Drug Screening Laboratories (Great Lakes, IL; Jacksonville, FL) - Headquarters Air Force Drug Testing Laboratory (Lackland AFB, TX) - Army Forensic Toxicology Drug Testing Laboratories (Fort Meade, MD; Fort Shafter Flats, HI) - Armed Forces Medical Examiner System (Dover AFB, DE) - Contracting offices in Norfolk, VA and Tripler AMC, HI

Description

The Department of War (DoW) Drug Demand Reduction Program (DDRP) has a requirement for Food & Drug Administration (FDA) and Quality Management Documented 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 reagent kits are required for an ordering period of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month.

Please see attached Statement of Work and copy of Solicitation N0018926RB011.  

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