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Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff

Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff

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FDA 官方历史目录记录;Final guidance;发布日期:2023-01-12。官方主题:Premarket, Coronavirus, CLIA (Clinical Laboratory Improvement Amendments), Immunology & Microbiology , IVDs (In Vitro Diagnostic Devices)。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov