- Country: USA
- Summary: Lateral Flow Assay (LFA) validation and manufacturing
- UST Ref No: 113559878
- Deadline: 31 Jan 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: HCKBG-2025-00447
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- Description:
- 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 ... - Documents:
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CLICK HERE TO LOGINLateral Flow Assay (LFA) validation and manufacturing - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | CENTERS FOR DISEASE CONTROL AND PREVENTION, a Government sector organization in USA, has announced a new tender for Lateral Flow Assay (LFA) validation and manufacturing. This tender is published on USARFP under UST Ref No: 113559878 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-01-31.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
