The State Food and drug administration has approved 30 novel coronavirus antigen detection reagents

2022-04-28

According to the official website of the State Food and drug administration, on April 27, the State Food and drug administration again reviewed and approved a novel coronavirus antigen detection reagent product. As of April 27, the State Food and drug administration has approved 30 novel coronavirus antigen detection reagent products. The State Food and Drug Administration said that the novel coronavirus antigen detection reagent is applicable to the population specified in the application scheme for novel coronavirus antigen detection (Trial) (joint prevention and control mechanism Zongfa [2022] No. 21). The drug regulatory department will strengthen the post marketing supervision of relevant products to protect the safety of patients. According to the data, on March 12, the State Food and Drug Administration issued a notice approving the application change for self-test application of novel coronavirus antigen products of Nanjing nuovizan, Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu biology and Beijing huaketai biology. On March 13, the State Food and Drug Administration approved the registration applications of five novel coronavirus antigen products, namely, Wantai biology, Rex biology, Tianjin BIOSIS biology, Chongqing Mingdao Jietai biology and Beijing Lepu diagnostics. On March 15, the State Food and Drug Administration approved the registration application of two novel coronavirus antigen products, namely Zhejiang Dongfang biology and Wuhan Mingde biology. On March 16, the State Food and Drug Administration approved the application for registration of novel coronavirus antigen products of Aikang Biotechnology (Hangzhou) Co., Ltd. On March 17, the State Food and Drug Administration approved the registration application of novel coronavirus antigen products of Zhongyuan Huiji Biotechnology Co., Ltd. On March 18, the State Food and Drug Administration approved the registration applications of three novel coronavirus antigen products, namely, Xiamen Aode biology, Shandong Kanghua biology and Hangzhou Aotai biology. On March 23, the State Food and Drug Administration approved the registration application of two novel coronavirus antigen products, namely, Shenzhen Yirui biology and Shenzhen yahuilong biology. On March 29, the State Food and Drug Administration approved the application for registration of novel coronavirus antigen products of Innotech (Tangshan) Biotechnology Co., Ltd. On March 30, the State Food and Drug Administration approved the registration application of novel coronavirus antigen products of Beijing Zhuocheng Huisheng Biotechnology Co., Ltd. On April 1, the State Food and Drug Administration approved the registration applications of two novel coronavirus antigen products, namely, Shanghai Xinchao biology and Nanjing Shenji pharmaceutical. On April 2, the State Food and Drug Administration approved the registration application of novel coronavirus antigen products of Shandong Boke Diagnostic Technology Co., Ltd. On April 12, the State Food and Drug Administration approved the registration application of two novel coronavirus antigen products, namely Zhuhai Lizhu reagent and Shanghai Berger medical. On April 13, the State Food and Drug Administration approved the application for registration of novel coronavirus antigen products of Fosun diagnostic technology (Shanghai) Co., Ltd. On April 20, the State Food and Drug Administration approved the application for registration of two novel coronavirus antigen products, namely, Hebei jingshuo biology and HaiHou (Hainan Free Trade Zone) medical. Screenshot of the official website of the State Food and Drug Administration (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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