FDA Guidance Documents·· 原文未提供具体时分
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
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FDA 官方历史目录记录；Final guidance；发布日期：1992-05-15。官方主题：Premarket, Laboratory Tests, 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