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31! State Food and Drug Administration approved Kehua biological novel coronavirus antigen detection reagent

On April twonine, the State Food and Drug Administration reviewed and approved one novel coronavirus antigen detection reagent product again. The approved product this time isShanghai Kehua Bioengineering Co., Ltd. developed and produced by colloidal gold method。 As of April twonine, the State Food and drug administration has approved threeone novel coronavirus antigen detection reagent products.

The novel coronavirus antigen detection reagent is applicable to the population specified in the application scheme for novel coronavirus antigen detection (Trial) (joint prevention and control mechanism Zongfa [two0twotwo] No. twoone).
The drug regulatory department will strengthen the post marketing supervision of relevant products to protect the safety of patients.

The State Food and drug administration has approved the novel coronavirus antigen detection reagent:

Serial number

Product name

Registrant

Registration Certificate No

one

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Guangzhou Wanfu Biotechnology Co., Ltd

National Machinery approvaltwenty billion two hundred and three million four hundred thousand eight hundred and thirty

two

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Beijing wojin Biotechnology Co., Ltd

National Machinery approvaltwo0two0threefour00eightthreeone

three

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (fluorescence immunochromatography)

Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd

National Machinery approvaltwo0two0threefour00ninefour0

four

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (fluorescence immunochromatography)

Beijing huaketai Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00three0eight

five

Novel coronavirus(two0onenine-nCoV)Antigen detection kit(Colloidal gold method)

Nanjing nuovizan Medical Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefoursix

six

novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Tianjin boasaisi Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefourseven

seven

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Beijing rejing Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefoureight

eight

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Chongqing Mingdao jietest Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefournine

nine

Novel coronavirus(two0onenine-nCoV)Antigen detection kit(Colloidal gold method)

Beijing Lepu Diagnostic Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefive0

one0

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Beijing Wantai Biological Pharmaceutical Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefiveone

oneone

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Zhejiang Dongfang gene biological products Co., Ltd

National Machinery approvaltwo0twotwothreefour00threefivenine

onetwo

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Wuhan Mingde Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threesix0

onethree

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Aikang Biotechnology (Hangzhou) Co., Ltd

National Machinery approvaltwo0twotwothreefour00threesixone

onefour

Novel coronavirus(two0onenine-nCoV)ResistprimaryTest kit(Colloidal gold method)

Zhongyuan Huiji Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threesixfive

onefive

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Xiamen Aode Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threeseveneight

onesix

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shandong Kanghua Biomedical Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threesevennine

oneseven

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Hangzhou Aotai Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threeeight0

oneeight

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (fluorescence immunochromatography)

Shenzhen Yirui Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threeninefour

onenine

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shenzhen yahuilong Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00threeninefive

two0

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Innotech (Tangshan) Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00four0four

twoone

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Beijing Zhuocheng Huisheng Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00four0seven

twotwo

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shanghai Xinchao Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00fourtwosix

twothree

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Nanjing Shenji Pharmaceutical Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00fourtwoseven

twofour

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shandong Boke Diagnostic Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00fourthree0

twofive

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Zhuhai Lizhu Reagent Co., Ltd

National Machinery approvaltwo0twotwothreefour00fourseven0

twosix

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shanghai Berger Medical Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00foursevenone

twoseven

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Fosun diagnostic technology (Shanghai) Co., Ltd

National Machinery approvaltwo0twotwothreefour00five0four

twoeight

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Hebei jingshuo Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00five0seven

twonine

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (latex method)

Haihatch (Hainan Free Trade Zone) Medical Technology Co., Ltd

National Machinery approvaltwo0twotwothreefour00five0eight

three0

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Wuhan shengzhiyuan Biotechnology Co., Ltd

National Machinery approvaltwo0twotwothreefour00fivesixseven

threeone

Novel coronavirus(two0onenine-nCoV)Antigen detection kit (colloidal gold method)

Shanghai Kehua Bioengineering Co., Ltd

National Machinery approvaltwo0twotwothreefour00fivesixeight