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China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval

Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 antibody testing an important supplement to nucleic acid testing. In the process of emergency approval, the Center for Medical Device Evaluation of the China National M...

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Detalles Bibliográficos
Autores principales:	Lv, Yunfeng, He, Jingyun, Liu, Rongzhi, Gao, Yu, Xu, Chao, Hu, Peng, Zheng, Shengwei, Fang, Li, Li, Ran, Han, Congyin, An, Juanjuan, Dong, Jinchun
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Newlands Press Ltd 2020
Materias:	Regulatory
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7784785/ https://www.ncbi.nlm.nih.gov/pubmed/33326307 http://dx.doi.org/10.4155/bio-2020-0188

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