Johnson R L
University of Massachusetts Medical School, Department of Pathology and Clinical Laboratories, Berkshire Medical Center, Pittsfield, 01201, USA.
Cytometry. 1999 Feb 15;38(1):40-1. doi: 10.1002/(sici)1097-0320(19990215)38:1<40::aid-cyto6>3.3.co;2-r.
In summary, the FDA Final Rule on Analyte Specific Reagents has provided clarity and simplification for manufactures to develop and market products. The burden of establishing performance characteristics is now the responsibility of the clinical flow cytometry laboratory. The FDA now requires a disclaimer to be included in every lab report utilizing these products.
总之，美国食品药品监督管理局（FDA）关于分析物特异性试剂的最终规定为制造商开发和销售产品提供了清晰性和简化。确定性能特征的责任现在落在临床流式细胞术实验室身上。FDA现在要求在使用这些产品的每份实验室报告中都包含一项免责声明。
