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 |