Opiate Immunoassay Test Reagent

Closed Solicitation Posted

Solicitation number
N6264523R0005
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
325413 In-Vitro Diagnostic Substance Manufacturing
PSC
6550 In Vitro Diagnostic Substances, Reagents, Test Kits And Sets
Place of performance
Frederick, Maryland 21702, United States

Notice details come from SAM.gov. Updated .

Notice text

2 versions

Update #2 · Latest ·

The Department of Defense (DOD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality management Documented Opiate immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting of hydrocodone, hydromorphone, codeine, and morphine in human urine samples. Proposals shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance of up to five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month.

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.

NOTE: The action previously designated as N6264522R0026 in FY22 has been replaced by this effort N6264523R0005 in FY23.

NOTE:  Due to system issues, drafts of the SF-30 Amendment P00001 and a Conform SF-1449 are being attached as stopgap documents.  As soon as the official SF-30 is generated these will be replaced.

Corrected documents are expected by 11-11-2022. 

Update #1 ·

The Department of Defense (DOD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality management Documented Opiate immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting of hydrocodone, hydromorphone, codeine, and morphine in human urine samples. Proposals shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance of up to five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month.

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.

NOTE: The action previously designated as N6264522R0026 in FY22 has been replaced by this effort N6264523R0005 in FY23.

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