Laboratory-Developed Tests in the New European Union 2017/746 Regulation: Opportunities and Risks

被引：13
|
作者：
Vogeser, Michael [1 ]
Brueggemann, Monika [2 ]
Lennerz, Jochen [3 ]
Stenzinger, Albrecht [4 ]
Gassner, Ulrich M. [5 ]
机构：
[1] Ludwig Maximilians Univ Munchen, Inst Lab Med, Univ Hosp, Marchioninistr 15, DE-81377 Munich, Germany
[2] Univ Hosp Schleswig Holstein, Dept Hematol, Kiel, Germany
[3] Massachusetts Gen Hosp, Harvard Med Sch, Ctr Integrated Diagnost, Boston, MA 02114 USA
[4] Univ Hosp Heidelberg, Inst Pathol, Heidelberg, Germany
[5] Univ Augsburg, Fac Law, Inst Med Device Law, Augsburg, Germany
来源：
CLINICAL CHEMISTRY | 2022年 / 68卷 / 01期
关键词：
FDA;
D O I：
10.1093/clinchem/hvab215
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
[No abstract available]
引用
收藏
页码：40 / 42
页数：3
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