# Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/revised-recommendations-regarding-invalidation-of-test-results-of-licensed-and-510k-cleared-bloodborne-pathogen-assays-used-to-test-donors-guidance-for-industry/0cda0e13-b5d9-4c9c-874d-d7dd38e5de33

> FDA guidance document: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors:  Guidance for Industry. Issue date: July 11, 2001. Get complete insights and analysis.

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## Details

- Title: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2001-07-11
- Last Changed: 2024-06-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0743">FDA-1999-D-0743</a>

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