Analysis of Class II Common Problems in the Registration of in Vitro Diagnostic Reagent (Kit) for Clinical Chemistry].

From the perspective of technical review, this paper made statistics on the supplement contents of in vitro diagnostic reagent (kit) for clinical chemistry registered in Zhejiang province in the past five years, summarized and analyzed the common problems, and put forward corresponding suggestions based on the common problems encountered in the public welfare training of registered specialists in Zhejiang province. The aim is to provide technical reference for registrars to prepare registration documents reasonably and efficiently and for review staffs to strengthen their points of focus.

Citation

Xiaohe Yang, Qinfang Dong, Wenwu Zhu, Hui Zhen. Analysis of Class II Common Problems in the Registration of in Vitro Diagnostic Reagent (Kit) for Clinical Chemistry]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation. 2020 Dec 08;44(6):537-540

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PMID: 33314864

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