Lateral Flow Assay (LFA) validation and manufacturing Tender, USA - 113559878

Procurement Summary

Country : USA

Summary : Lateral Flow Assay (LFA) validation and manufacturing

Deadline : 31 Jan 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 113559878

Document Ref. No. : HCKBG-2025-00447

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

The following is a Sources Sought Notice. The Government is seeking to identify qualified sources under North American Industry Classification System (NAICS) 334516 - Analytical Laboratory Instrument Manufacturing. This Sources Sought Notice is for market research information only and is to be used for preliminary planning purposes. No proposals are being requested and none will be accepted in response to this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS, AND NO CONTRACT WILL BE AWARDED FROM THIS NOTICE, nor does it restrict the Government as to the ultimate acquisition approach.

The Centers for Disease Control and Prevention-s (CDC) Laboratory Branch seeks an established medical device company with the proven capabilities and expertise required to manufacture and validate the performance of lateral flow devices. Commercial medical device companies are sought with demonstrated success in producing large-scale lateral flow kits under good manufacturing practices to produce kits containing lateral flow assays with associated buffers, lancets, and instructions.

A Contractor will manufacture 25, 000 lateral flow devices to be used in pre-clinical and clinical studies evaluating their performance and utility in rapidly diagnosing HIV antiretroviral usage in point-of-care facilities. The Government will provide the technical design and the Contractor will need to adapt the design to its production pipeline to produce tests that meet the optimal test design specifications. The Contractor will optimize the test performance in their production system and provide the Government with 100 prototype tests for validation prior to selection of the final design for large-scale production. The Contractor may need to perform multiple rounds of optimization to achieve required test performance. The Contractor will perform an assessment of shelf-life for the finalized lateral flow kit. After Government-s validation and acceptance, the Contractor will produce ...
Active Contract Opportunity
Notice ID : HCKBG-2025-00447
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : CENTERS FOR DISEASE CONTROL AND PREVENTION
Office: CDC OFFICE OF ACQUISITION SERVICES
General Information
Contract Opportunity Type: Sources Sought (Original)
Original Published Date: Jan 21, 2025 11:35 am EST
Original Response Date: Jan 31, 2025 12:00 pm EST
Inactive Policy: 15 days after response date
Original Inactive Date: Feb 15, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code:
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance: Atlanta, NY USA

Documents

 Tender Notice