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.
ID: N0018924RZ162Type: Combined Synopsis/Solicitation
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE NAVYNAVSUP FLT LOG CTR NORFOLKNORFOLK, VA, 23511-3392, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS (6550)

Original Source

https://sam.gov/opp/d84feb886fdf451098fa8b4036f9b57d/view
Timeline
    Description

    The Department of Defense, specifically the Navy Medical Readiness Logistics Command Detachment Fort Detrick, is seeking proposals for the procurement of FDA-approved Immunoassay Reagent Kits designed for the detection of 6-acetylmorphine (6AM) in urine samples. The contract requires vendors to provide reagent kits compatible with Beckman Coulter AU5800 series analyzers, capable of conducting up to 500,000 tests per month over a five-year period, while adhering to stringent FDA and quality management documentation standards. This procurement is critical for the Drug Demand Reduction Program, ensuring accurate and reliable drug testing within the Department of Defense. Interested vendors must submit technical documentation by October 25, 2024, with final quotes due by November 22, 2024. For further inquiries, contact James Berghaier at 215-697-2022 or via email at james.berghaier@navy.mil.

    Point(s) of Contact
    James Berghaier 215-697-2022 James.W.Berghaier.civ@us.navy.mil
    james.berghaier@navy.mil
    Gerald Bowne
    gerald.l.bowne.civ@us.navy.mil
    Files
    Title
    Posted
    N0018924RZ162.pdf
    This document pertains to a Request for Proposal (RFP) issued by the Navy for the procurement of FDA-approved Immunoassay Reagent Kits designed to detect 6-acetylmorphine (6AM) in urine samples. The contract emphasizes the necessity for robust documentation including FDA and ISO certifications, product specifications, and compliance attestations from Original Equipment Manufacturers (OEM) or authorized distributors. The proposal timeline requires submission of technical documentation by October 25, 2024, with final quotes due by November 22, 2024. The statement of work outlines requirements for sensitivity, specificity, and performance in conjunction with Beckman Coulter AU5800 series analyzers. Contractors must ensure monthly delivery capacity of reagents to facilitate up to 500,000 tests monthly, highlighting the operational scale. Quality assurance standards must align with FDA regulations and involve thorough testing, calibration, and compliance reporting. The contract prioritizes small business participation, particularly service-disabled veteran-owned and women-owned businesses. The document’s structure delineates solicitation guidelines, submission processes, evaluation criteria, and compliance expectations, reinforcing the government's commitment to maintaining high safety and quality standards in procurement.
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