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.