Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests

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作者： Caliendo, Angela M. ^[1] ; Couturier, Marc R. ^[2] ; Ginocchio, Christine C. ^[3] ; Hanson, Kimberly E. ^[4] ; Miller, Melissa B. ^[5] ; Walker, Kimberly E. ^[6] ; Frank, Gregory M. ^[7]

作者单位： Amer Soc Microbiol, Washington, DC USA ^[1] Univ Utah, Dept Med, Div Infect Dis, Salt Lake City, UT 84112 USA ^[2] Brown Univ, Dept Med, Alpert Med Sch, Providence, RI 02912 USA ^[3] Hofstra North Shore LIJ Sch Med, Hempstead, NY USA ^[4] Infect Dis Soc Amer, Arlington, VA USA ^[5] UNC Hlth Care, Clin Mol Microbiol Lab, Chapel Hill, NC USA ^[6] Univ Utah, Dept Pathol, ARUP Labs, Salt Lake City, UT USA ^[7]

关键词 laboratory-developed tests LDT FDA infectious diseases diagnostics

发布时间 2018-06-23

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