The Department of the Navy has a requirement for FDA and Quality Management Documented THC9-COOH immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting THC9-COOH in human urine samples. Key features of the reagent kits include compatibility with the Beckman Coulter AU5800 series systems, ability to detect THC9-COOH at concentrations equal to or greater than 50 ng/mL, and compliance with FDA requirements.
The following are key points to consider for this opportunity:
• The reagent kits must be compatible with the Beckman Coulter AU5800 series systems.
• The reagent kits must be capable of detecting THC9-COOH in human urine samples at concentrations equal to or greater than 50 ng/mL.
• The reagent kits must comply with FDA requirements.
• The contractor must provide a unique item identifier for delivered items.
• The contractor must report certain information at the time of delivery, including the unique item identifier, unique item identifier type, and enterprise identifier.
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