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The State Food and Drug Administration has approved 48 new coronavirus antigen detection reagents

 Last Update: 2023-02-03
 Source: Internet
 Author: User

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On December 28, after the review of the State Food and Drug Administration, the new coronavirus antigen detection reagent product of Jiangsu Hongweites Pharmaceutical Technology Co.
, Ltd.
was approved
.
Up to now, the State Food and Drug Administration has approved 48 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.
Annex: New coronavirus antigen detection reagents approved by the State Food and Drug Administration

serial number	Product name	Registrant	Registration certificate number
1	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Guangzhou Wanfu Biotechnology Co. , Ltd	National weapons are approved 20203400830
2	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Beijing Kingwolf Bioengineering Technology Co. , Ltd	National Arms Approval 20203400831
3	Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography)	Shenzhen Huada Inyuan Pharmaceutical Technology Co. , Ltd	National Arms Note 20203400940
4	Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography)	Beijing Huaketai Biotechnology Co. , Ltd	National Arms Note 20223400308
5	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Nanjing Novezan Medical Technology Co. , Ltd	National Arms Annotation 20223400346
6	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Tianjin Boossyth Biotechnology Co. , Ltd	National Arms Note 20223400347
7	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Hotjing Biotechnology Co. , Ltd	National Arms Note 20223400348
8	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Chongqing Mingdao Jietai Biotechnology Co. , Ltd	National weapons are approved 20223400349
9	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Lepu Diagnostic Technology Co. , Ltd	National Arms Note 20223400350
10	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Wantai Biopharmaceutical Co. , Ltd	National Arms Note 20223400351
11	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhejiang Dongfang Gene Biological Products Co. , Ltd	National weapons are approved 20223400359
12	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Wuhan Mingde Biotechnology Co. , Ltd	National Arms Note 20223400360
13	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Ikang Biotechnology (Hangzhou) Co. , Ltd	National Arms Note 20223400361
14	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhongyuan Huiji Biotechnology Co. , Ltd	National Arms Note 20223400365
15	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Xiamen Aude Biotechnology Co. , Ltd	National Arms Note Approval 20223400378
16	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shandong Kanghua Biomedical Technology Co. , Ltd	National Arms Note 20223400379
17	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Hangzhou Aotai Biotechnology Co. , Ltd	National Arms Note 20223400380
18	Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Fluorescence Immunochromatography)	Shenzhen Yirui Biotechnology Co. , Ltd	National Arms Note 20223400394
19	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shenzhen Yahuilong Biotechnology Co. , Ltd	National Arms Note 20223400395
20	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Innote (Tangshan) Biotechnology Co. , Ltd	National Arms Note 20223400404
21	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Zhuocheng Wison Biotechnology Co. , Ltd	National Arms Note 20223400407
22	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shanghai Xinchao Biotechnology Co. , Ltd	National Arms Approval 20223400426
23	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Nanjing Shenji Pharmaceutical Technology Co. , Ltd	National Arms Note 20223400427
24	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shandong Brocade Diagnostic Technology Co. , Ltd	National Arms Note 20223400430
25	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Zhuhai Lizhu Reagent Co. , Ltd	National Arms Note 20223400470
26	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shanghai Berger Medical Technology Co. , Ltd	National Arms Note 20223400471
27	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Fosun Diagnostic Technology (Shanghai) Co. , Ltd	National Arms Note 20223400504
28	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Hebei Jingshuo Biotechnology Co. , Ltd	National Arms Note 20223400507
29	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Hainan Free Trade Zone Medical Technology Co. , Ltd	National Arms Note 20223400508
30	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Wuhan Shengzhiyuan Biotechnology Co. , Ltd	National weapons are approved 20223400567
31	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shanghai Kehua Bioengineering Co. , Ltd	National weapons are approved 20223400568
32	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Xiamen Baotai Biotechnology Co. , Ltd	National weapons are approved 20223400682
33	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Shanghai Zhijiang Biotechnology Co. , Ltd	National weapons are approved 20223401080
34	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Wuxi Kezhida Technology Co. , Ltd	National weapons are approved 20223401224
35	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Biohan Biotechnology (Hefei) Co. , Ltd	National weapons are approved 20223401539
36	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Jiangsu Meike Medical Technology Co. , Ltd	National weapons are approved 20223401588
37	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Bioda Biotechnology (Wuhan) Co. , Ltd	National weapons are approved 20223401610
38	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Key Egg Biotechnology Co. , Ltd	National weapons are approved 20223401613
39	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Temp Bioscience (China) Co. , Ltd	National weapons are approved 20223401614
40	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhongshan Bioengineering Co. , Ltd	National weapons are approved 20223401617
41	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhengzhou Antu Bioengineering Co. , Ltd	National weapons are approved 20223401620
42	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Xiamen is Positive Biotechnology Co. , Ltd	National weapons are approved 20223401621
43	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Avico Biotechnology Co. , Ltd	National weapons are approved 20223401763
44	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Mike Biotech, Inc	National weapons are approved 20223401764
45	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Dana (Tianjin) Biotechnology Co. , Ltd	National weapons are approved 20223401793
46	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Bell Bioengineering Co. , Ltd	National weapons are approved 20223401794
47	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Hangzhou Xiehe Medical Supplies Co. , Ltd	National weapons are approved 20223401809
48	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Jiangsu Hongweites Pharmaceutical Technology Co. , Ltd	National weapons are approved 20223401815

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