Registration Information of New Coronavirus Detection Reagents of SFDA

Apr. 28,2020

Registration Information of New Coronavirus Detection Reagents of the State Food and Drug Administration Serial Number Registration Certificate Number Product Name Registrant 1 National Machinery Approval 20203400057 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) Shanghai Zhijiang Biotechnology Co., Ltd. 2 Countries Mechanical injection standard 20203400058 new coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) Shanghai Jienuo Biological Technology Co., Ltd. 3 National mechanical injection standard 20203400059 new coronavirus 2019-nCoV nucleic acid detection kit (joint probe anchored polymer sequencing) Law) Huada Biotechnology (Wuhan) Co., Ltd. 4 National Machinery Injection Standard 20203400060 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method) Huada Biotechnology (Wuhan) Co., Ltd. 5 National Machinery Injection Standard 20203400063 New Coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) Sun Yat-Sen University Daan Gene Co., Ltd. 6 National Machinery Approval 20203400064 new coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) Shengxiang Biotechnology Co., Ltd. 7 countries Mechanical injection standard 20203400065 new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PC Method R) Shanghai Bojie Medical Technology Co., Ltd. 8 SINOMACH injection 20203400176 New Coronavirus (2019-nCoV) antibody detection kit (colloidal gold method) Guangzhou Wanfu Biotechnology Co., Ltd. 9 SINOMACH injection 20203400177 new coronavirus (2019-nCoV) IgM / IgG antibody detection kit (colloidal gold method) Innotech (Tangshan) Biotechnology Co., Ltd. 10 National Machinery Injection Standard 20203400178 Six-respiratory virus nucleic acid detection kit (thermostatic amplification chip method) Chengdu Bo Aojingxin Biotechnology Co., Ltd. 11 National Machinery Injection Standard 20203400179 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method) Beijing Zhuocheng Wison Biotechnology Co., Ltd. 12 National Machinery Injection Standard 20203400182 New Coronavirus (2019- nCoV) IgM antibody detection kit (magnetic particle chemiluminescence method) Boozis (Chongqing) Biotechnology Co., Ltd. 13 National Machinery Injection Standard 20203400183 New Coronavirus (2019-nCoV) IgG antibody detection kit (magnetic particle chemiluminescence method) Boozis (Chongqing) Biotechnology Co., Ltd. 14 SINOMACH is looking for 20203400184 new coronavirus 2019-nCoV nuclear Acid detection kit (Fluorescence PCR method) Mike Biological Co., Ltd. 15 National Machinery Injection Standard 20203400198 New Coronavirus (2019-nCoV) antibody detection kit (magnetic particle chemiluminescence method) Xiamen Wantai Kerry Biotechnology Co., Ltd. 16 countries Mechanical injection standard 20203400199 new coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) Guangdong Hexin Health Technology Co., Ltd. 17 National mechanical injection standard 20203400212 new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method) Wuhan Mingde Biotechnology Co., Ltd. 18 National Machinery Injection Standard 20203400239 New Coronavirus (2019-nCoV) IgM / IgG Antibody Detection Kit (Colloidal Gold Method) Nanjing Nuoweizan Medical Technology Co., Ltd. 19 National Machinery Injection Standard 20203400240 New Coronavirus (2019-nCoV) IgM / IgG antibody detection kit (colloidal gold method) Zhuhai Livzon Reagent Co., Ltd. 20 National Machinery Standard 20203400241 New Coronavirus 2019-nCoV nucleic acid detection kit (thermostatic amplification-real-time fluorescence method) Hangzhou Ustar Biotechnology Co., Ltd. 21 National Machinery Injection Standard 20203400298 New Coronavirus 2019-nCoV nucleic acid detection Kit (Hybrid Capture Immunofluorescence Method) Anbang (Xiamen) Biotechnology Co., Ltd. 22 SINOMACH Note 20203400299 New Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method) Shanghai Fosun Changzheng Medical Science Co., Ltd. 23 National Machinery Injection Standard 20203400300 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (RNA Capture Probe Method) Shanghai Rendu Biotechnology Co., Ltd. 24 National Machinery Injection Standard 20203400301 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (RNA Constant Temperature Amplification) -Gold Probe Chromatography) Wuhan Zhongzhi Biotechnology Co., Ltd. 25 National Machinery Injection Standard 20203400302 New Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Double Amplification Method) Wuhan Zhongzhi Biotechnology Co., Ltd.

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