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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration Staff

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry 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:2017-09-15。官方主题:Premarket, Microbiology, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Premarket Approval (PMA)。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov