Chinanews.com, December 23. According to the website of the State Food and Drug Administration, on December 23, after review by the State Food and Drug Administration, Dana (Tianjin) Biotechnology Co., Ltd. and Beijing Bell Bioengineering Co., Ltd. approved the two New coronavirus antigen detection reagent products.
Up to now, the State Food and Drug Administration has approved 46 new coronavirus antigen detection reagent products.
The drug supervision and management department will strengthen the post-market supervision of relevant products to protect the safety of patients with medical devices.
Attachment: Novel Coronavirus Antigen Detection Reagent Approved by the State Food and Drug Administration
serial number | product name | registrant | registration number |
1 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Guangzhou Wanfu Biotechnology Co., Ltd. | National Machinery Note 20203400830 |
2 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Beijing Jinwofu Biological Engineering Technology Co., Ltd. | National Machinery Note 20203400831 |
3 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. | National Machinery Note 20203400940 |
4 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Beijing Huaketai Biotechnology Co., Ltd. | National Machinery Note 20223400308 |
5 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Nanjing Nuoweizan Medical Technology Co., Ltd. | National Machinery Note 20223400346 |
6 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Tianjin Boasis Biotechnology Co., Ltd. | National Machinery Note 20223400347 |
7 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Rejing Biotechnology Co., Ltd. | National Machinery Note 20223400348 |
8 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Chongqing Mingdao Quick Test Biotechnology Co., Ltd. | National Machinery Note 20223400349 |
9 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Lepu Diagnostics Technology Co., Ltd. | National Machinery Note 20223400350 |
10 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Wantai Biopharmaceutical Co., Ltd. | National Machinery Note 20223400351 |
11 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhejiang Dongfang Gene Biological Products Co., Ltd. | National Machinery Note 20223400359 |
12 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuhan Mingde Biotechnology Co., Ltd. | National Machinery Note 20223400360 |
13 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Aikon Biotechnology (Hangzhou) Co., Ltd. | National Machinery Note 20223400361 |
14 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhongyuan Huiji Biotechnology Co., Ltd. | National Machinery Note 20223400365 |
15 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Xiamen Aode Biotechnology Co., Ltd. | National Machinery Note 20223400378 |
16 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shandong Kanghua Biomedical Technology Co., Ltd. | National Machinery Note 20223400379 |
17 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Hangzhou Aotai Biotechnology Co., Ltd. | National Machinery Note 20223400380 |
18 | Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography) | Shenzhen Yirui Biotechnology Co., Ltd. | National Machinery Note 20223400394 |
19 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shenzhen Yahuilong Biotechnology Co., Ltd. | National Machinery Note 20223400395 |
20 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Innotech (Tangshan) Biotechnology Co., Ltd. | National Machinery Note 20223400404 |
twenty one | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Zhuocheng Wison Biotechnology Co., Ltd. | National Machinery Note 20223400407 |
twenty two | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Xinchao Biotechnology Co., Ltd. | National Machinery Note 20223400426 |
twenty three | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Nanjing Shenji Pharmaceutical Technology Co., Ltd. | National Machinery Note 20223400427 |
twenty four | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shandong Brocade Diagnostic Technology Co., Ltd. | National Machinery Note 20223400430 |
25 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Zhuhai Livzon Reagent Co., Ltd. | National Machinery Note 20223400470 |
26 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Berger Medical Technology Co., Ltd. | National Machinery Note 20223400471 |
27 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Fosun Diagnostics (Shanghai) Co., Ltd. | National Machinery Note 20223400504 |
28 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Hebei Jingshuo Biotechnology Co., Ltd. | National Machinery Note 20223400507 |
29 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Haicuo (Hainan Free Trade Zone) Medical Technology Co., Ltd. | National Machinery Note 20223400508 |
30 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuhan Shengzhiyuan Biotechnology Co., Ltd. | National Machinery Note 20223400567 |
31 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Kehua Biological Engineering Co., Ltd. | National Machinery Note 20223400568 |
32 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Xiamen Biotime Biotechnology Co., Ltd. | National Machinery Note 20223400682 |
33 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Shanghai Zhijiang Biotechnology Co., Ltd. | State Machinery Note 20223401080 |
34 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Wuxi Kezhida Technology Co., Ltd. | National Machinery Note 20223401224 |
35 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Biohim Biotechnology (Hefei) Co., Ltd. | National Machinery Note 20223401539 |
36 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Jiangsu Meike Medical Technology Co., Ltd. | National Machinery Note 20223401588 |
37 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Bioda Biotechnology (Wuhan) Co., Ltd. | National Machinery Note 20223401610 |
38 | Novel coronavirus (2019-nCoV) antigen detection kit (latex method) | Jidan Biotechnology Co., Ltd. | National Machinery Note 20223401613 |
39 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Top Bioscience (China) Co., Ltd. | National Machinery Note 20223401614 |
40 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhongshan Bioengineering Co., Ltd. | National Machinery Note 20223401617 |
41 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Zhengzhou Antu Biological Engineering Co., Ltd. | National Machinery Note 20223401620 |
42 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Xiamen Weizheng Biotechnology Co., Ltd. | National Machinery Note 20223401621 |
43 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Aveco Biotechnology Co., Ltd. | National Machinery Note 20223401763 |
44 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | mike bio co., ltd. | National Machinery Note 20223401764 |
45 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Dana (Tianjin) Biotechnology Co., Ltd. | National Machinery Note 20223401793 |
46 | Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) | Beijing Bell Bioengineering Co., Ltd. | National Machinery Note 20223401794 |