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The State Food and Drug Administration has approved 29 new coronavirus antigen detection reagents

 Last Update: 2022-05-17
 Source: Internet
 Author: User

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antigen antibody reaction

gpi drug

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On April 20, the State Food and Drug Administration reviewed and approved two new coronavirus antigen detection reagent products again
.
As of April 20, the State Food and Drug Administration has approved 29 new coronavirus antigen detection reagent products
.
The new coronavirus antigen detection reagent is suitable for the population specified in the "New Coronavirus Antigen Detection Application Plan (Trial)" (Zongfa [2022] No.
21 of the Joint Prevention and Control Mechanism)
.
The drug supervision and administration department will strengthen post-market supervision of related products to protect the safety of patients using devices
.
The following is the list of new coronavirus antigen detection reagents approved by the State Food and Drug Administration: Serial No.
Product Name Registrant Registration Certificate No.
1 Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) Guangzhou Wanfu Biotechnology Co.
, Ltd.
20203400830 2 Novel coronavirus (2019-nCoV) antigen detection kit (latex method) Beijing Jinwofu Bioengineering Technology Co.
, Ltd.
National Machinery 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 Novizan Medical Technology Co.
, Ltd.
National Machinery Note 20223400346 6 Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) ) Tianjin Boaosaisi Biotechnology Co.
, Ltd.
National Machinery Note 20223400347 7 Novel Coronavirus

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