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On December 11, after the review of the State Food and Drug Administration, Zhongshan Bioengineering Co.
, Ltd.
approved the new coronavirus antigen detection reagent product
of Zhongshan Bioengineering Co.
, Ltd.
Up to now, the State Food and Drug Administration has approved 40 new coronavirus antigen detection reagent products
.
The drug regulatory department will strengthen the post-marketing supervision of relevant products to protect the safety of
patients' devices.
The State Food and Drug Administration has approved the new coronavirus antigen detection reagent
| serial number | Product name | Registrant | Registration certificate number |
| 1 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Guangzhou Wanfu Biotechnology Co. | National weapons are approved 20203400830 |
| 2 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Beijing Kingwolf Bioengineering Technology Co. | National Arms Approval 20203400831 |
| 3 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Shenzhen Huada Inyuan Pharmaceutical Technology Co. | National Arms Note 20203400940 |
| 4 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Beijing Huaketai Biotechnology Co. | National Arms Note 20223400308 |
| 5 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Nanjing Novezan Medical Technology Co. | National Arms Annotation 20223400346 |
| 6 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Tianjin Boossyth Biotechnology Co. | National Arms Note 20223400347 |
| 7 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Hotjing Biotechnology Co. | National Arms Note 20223400348 |
| 8 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Chongqing Mingdao Jietai Biotechnology Co. | National weapons are approved 20223400349 |
| 9 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Lepu Diagnostic Technology Co. | National Arms Note 20223400350 |
| 10 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Wantai Biopharmaceutical Co. | National Arms Note 20223400351 |
| 11 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhejiang Dongfang Gene Biological Products Co. | National weapons are approved 20223400359 |
| 12 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuhan Mingde Biotechnology Co. | National Arms Note 20223400360 |
| 13 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Ikang Biotechnology (Hangzhou) Co. | National Arms Note 20223400361 |
| 14 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhongyuan Huiji Biotechnology Co. | National Arms Note 20223400365 |
| 15 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Xiamen Aude Biotechnology Co. | National Arms Note Approval 20223400378 |
| 16 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shandong Kanghua Biomedical Technology Co. | National Arms Note 20223400379 |
| 17 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Hangzhou Aotai Biotechnology Co. | National Arms Note 20223400380 |
| 18 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Shenzhen Yirui Biotechnology Co. | National Arms Note 20223400394 |
| 19 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shenzhen Yahuilong Biotechnology Co. | National Arms Note 20223400395 |
| 20 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Innote (Tangshan) Biotechnology Co. | National Arms Note 20223400404 |
| 21 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Zhuocheng Wison Biotechnology Co. | National Arms Note 20223400407 |
| 22 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Xinchao Biotechnology Co. | National Arms Approval 20223400426 |
| 23 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Nanjing Shenji Pharmaceutical Technology Co. | National weapons are approved 20223400427 |
| 24 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shandong Brocade Diagnostic Technology Co. | National weapons are approved 20223400430 |
| 25 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Zhuhai Lizhu Reagent Co. | National weapons are approved 20223400470 |
| 26 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Berger Medical Technology Co. | National weapons are approved 20223400471 |
| 27 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Fosun Diagnostic Technology (Shanghai) Co. | National weapons are approved 20223400504 |
| 28 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Hebei Jingshuo Biotechnology Co. | National weapons are approved 20223400507 |
| 29 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Hainan Free Trade Zone Medical Technology Co. | National weapons are approved 20223400508 |
| 30 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuhan Shengzhiyuan Biotechnology Co. | National weapons are approved 20223400567 |
| 31 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Kehua Bioengineering Co. | National weapons are approved 20223400568 |
| 32 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Xiamen Baotai Biotechnology Co. | National weapons are approved 20223400682 |
| 33 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Zhijiang Biotechnology Co. | National weapons are approved 20223401080 |
| 34 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuxi Kezhida Technology Co. | National weapons are approved 20223401224 |
| 35 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Biohan Biotechnology (Hefei) Co. | National weapons are approved 20223401539 |
| 36 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Jiangsu Meike Medical Technology Co. | National weapons are approved 20223401588 |
| 37 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Bioda Biotechnology (Wuhan) Co. | National weapons are approved 20223401610 |
| 38 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Key Egg Biotechnology Co. | National weapons are approved 20223401613 |
| 39 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Temp Bioscience (China) Co. | National weapons are approved 20223401614 |
| 40 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhongshan Bioengineering Co. | National weapons are approved 20223401617 |
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