On April 13, National Medical Products Administrations (NMPA) reviewed and approved Zhuhai Livzon Diagnostics Inc. and Shanghai BioGerm Medical Technology Co., Ltd's COVID-19 Antigen Test.
As of now，NMPA has approved 26 COVID-19 Antigen Test products.
|
COVID-19 Antigen Detection Reagent Approved by NMPA |
|||
|
NO. |
Product Name |
Company Name |
Certificate Number |
|
1 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Guangzhou Wondfo Biotech Co.,Ltd. |
|
|
2 |
SARS-CoV-2 Antigen Test（latex） |
Beijing Jinwofu Bioengineering Technology Co., Ltd. |
20203400831 |
|
3 |
SARS-CoV-2 Antigen Test（Fluorescence Immunochromatography） |
Bgi Pathogenesis Pharmaceutical Technology Co., Ltd |
20203400940 |
|
4 |
SARS-CoV-2 Antigen Test（Fluorescence Immunochromatography） |
Beijing Savant Biotechnology Co.,Ltd. |
20223400308 |
|
5 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Nanjing Vazyme Biotech Co.,Ltd. |
20223400346 |
|
6 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Boosse (Tianjin) Biotechnology Co., Ltd. |
20223400347 |
|
7 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Beijing Hotgen Biotech Co.,ltd. |
20223400348 |
|
8 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Chongqing M&d Biotechnology Co. Ltd |
20223400349 |
|
9 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Lepu Medical Technology(Beijing)Co.,Ltd. |
20223400350 |
|
10 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. |
20223400351 |
|
11 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Zhejiang Orient Gene Biotech Co.,Ltd. |
20223400359 |
|
12 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Wuhan Easy Diagnosis Biomedicine Co.,ltd. |
20223400360 |
|
13 |
SARS-CoV-2 Antigen Test（latex） |
Acon Biotech (Hangzhou) Co., Ltd. |
20223400361 |
|
14 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Zybio Inc. |
20223400365 |
|
15 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Xiamen AmonMed Biotechnology Co., Ltd. |
20223400378 |
|
16 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Weifang Kanghua Biotech Co., Ltd. |
20223400379 |
|
17 |
SARS-CoV-2 Antigen Test（latex） |
Hangzhou Alltest Biotech Co.,Ltd. |
20223400380 |
|
18 |
SARS-CoV-2 Antigen Test（Fluorescence Immunochromatography） |
Shenzhen Bioeasy Biotechnology Co.,ltd. |
20223400394 |
|
19 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Shenzhen YHLO Biotech Co.,Ltd. |
20223400395 |
|
20 |
SARS-CoV-2 Antigen Test（latex） |
Innovita Biological Technology Co., Ltd. |
20223400404 |
|
21 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Beijing Applied Biological Technologies Co.,Ltd. |
20223400407 |
|
22 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
SHANGHAI OUTDO BIOTECH CO.,LTD. |
20223400426 |
|
23 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Nanjing Synthgene Medical Technology Co., Ltd. |
20223400427 |
|
24 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Biobase Scientific(Shandong)Co.,Ltd |
20223400430 |
|
25 |
SARS-CoV-2 Antigen Test（latex） |
Zhuhai Livzon Diagnostics Inc. |
20223400470 |
|
26 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
Shanghai BioGerm Medical Technology Co., Ltd |
20223400471 |
At present, those who have obtained registration certificates for both COVID-19 Real-time and antigen test include Acon Biotech, Applied Biological, BioGerm Medical, Easy Diagnosis, Orient Gene Biotech and Zybio.
|
Company Name |
Certificate Number |
Product Name |
|
Acon Biotech (Hangzhou) Co., Ltd. |
20223400017 |
COVID-19 Real-time PCR Kit |
|
20223400361 |
SARS-CoV-2 Antigen Test（latex） |
|
|
Beijing Applied Biological Technologies Co.,Ltd. |
20203400179 |
COVID-19 Real-time PCR Kit |
|
20223400407 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
|
|
Shanghai BioGerm Medical Technology Co., Ltd |
20203400065 |
COVID-19 Real-time PCR Kit |
|
20213400714 |
COVID-19 Real-time Thermostatic CRISPR kit |
|
|
20223400471 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
|
|
Wuhan Easy Diagnosis Biomedicine Co.,ltd. |
20203400212 |
COVID-19 Real-time PCR Kit |
|
20223400360 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
|
|
Zhejiang Orient Gene Biotech Co.,Ltd. |
20203400520 |
COVID-19 Real-time PCR Kit |
|
20223400359 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
|
|
Zybio Inc. |
20213400228 |
COVID-19 Real-time PCR Kit |
|
20223400365 |
SARS-CoV-2 Antigen Test (Colloidal Gold Method) |
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