Fentanyl Immunoassay Reagent Test Kits (Fda Approved) Tender, USA - 78982023

Procurement Summary

Country : USA

Summary : Fentanyl Immunoassay Reagent Test Kits (Fda Approved)

Deadline : 03 Mar 2023

Other Information

Notice Type : Tender

TOT Ref.No.: 78982023

Document Ref. No. : N6264523R0001

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

The Naval Medical Readiness Logistics Command intends to issue a full and open solicitation for the purchase of U.S. Food and Drug Administration (FDA) approved fentanyl immunoassay (IA) drug testing reagent kits for detection in human urine samples in support of the Department of Defense (DoD) Drug Demand Reduction Program (DDRP).

General Requirements. The kits will be used as the initial (screen) IA for the detection of fentanyl in urine when present (and FDA approved) at a concentration equal to or greater than 1 ng/mL. Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry analyzers (purchased from Siemens Healthcare Diagnostics). The Government analyzer will be calibrated at 1 ng/mL using DoD prepared and certified solutions containing fentanyl.

The IA is limited to a two (2) reagent assay procedure. Reagents which require a separate pre-treatment of each specimen prior to testing on the analyzer are not considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the proposed reagent on the analyzer. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DoDI 1010.16 Rev. (June 15, 2020).

Interested offerors shall be the 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. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Repackaging or relabeling of an OEM-s reagents prod...
Active Contract Opportunity
Notice ID : N6264523R0001
Related Notice
Department/Ind. Agency : DEPT OF DEFENSE
Sub-tier : DEPT OF THE NAVY
Major Command : NAVSUP
Sub Command : NAVSUP OTHER HCA
Sub Command 2 : BUMED
Sub Command 3 : NAVY MEDICINE SUPPORT COMMAND
Office : NAVAL MEDICAL LOGISTICS COMMAND
General Information
Contract Opportunity Type: Presolicitation (Original)
All Dates/Times are: (UTC-05:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Feb 16, 2023 10:46 am EST
Original Response Date: Mar 03, 2023 11:00 am EST
Inactive Policy: Manual
Original Inactive Date: Apr 03, 2023
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6550 - IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS
NAICS Code: 325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance: USA

Documents

 Tender Notice