Food and Drug Administration (Fda) Approved Tender in USA - 71997504

Procurement Summary

Country: USA

Summary: Food and Drug Administration (Fda) Approved and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits

Deadline: 06 Oct 2022

Posting Date: 21 Sep 2022

Other Information

Notice Type: Tender

TOT Ref.No.: 71997504

Document Ref. No.: N62645FY23DDRP

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

Description
1. Notice. This Request for Information (RFI) is issued for informational purposes and market research only; it does not constitute a solicitation. The Government will not reimburse any company or individual for any expenses associated with preparing/submitting information in response to this posting, and any costs incurred are not considered allowable direct charges to other contracts or tasking. The information provided may be used by the Government in developing its acquisition strategy, statement of work/statement of objectives, and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained within their response.
2. Scope. The Naval Medical Readiness Logistics Command-Detachment Fort Detrick is conducting market research to identify possible sources in the commercial marketplace capable of providing United States Food and Drug Administration (FDA) approved and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits (hereafter referred to as Reagent/Kit(s)) for use with the currently installed Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. The NAICS Code is 325413 In-Vitro Diagnostic Substance Manufacturing; the Product Service Code is 6550 In Vitro Diagnostic Substances, Reagents, Test Kits and Sets.
2.1. The Kits shall be for the initial (screen) immunoassay* for the detection of fentanyl in urine when present at a concentration equal to or greater than 1 ng/mL using AU5800 Series Clinical Chemistry Analyzers calibrated at 1 ng/mL using DOD FTDTL-prepared and -certified solutions containing fentanyl.
*Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology...
Active Contract Opportunity

Notice ID : N62645FY23DDRP

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: Sources Sought (Original)

All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA

Original Published Date: Sep 20, 2022 08:02 pm EDT

Original Response Date: Oct 06, 2022 09:00 am EDT

Inactive Policy: 15 days after response date

Original Inactive Date:

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

Fentanly-RFI.docx