FDA Guidance Documents·· 原文未提供具体时分
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
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FDA 官方历史目录记录；Final guidance；发布日期：2013-03-27。官方主题：Premarket, Laboratory Tests。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov