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Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

China·CN-MF-000013495

Last updated September 18, 2026

About

Founded in 2002 by President Dr. Gongxiang Chen, Hangzhou GENESIS Biodetection & Biocontrol Co., Ltd. (GENESIS Group) has been enjoying an renowned reputation for more than 20 years in the field of IVD (In Vitro Diagnostic Devices) in China and all over the world, including the US, European countries and Asia.

From the manufacturer's own website. Source

What Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. makes

The company manufactures general specimen collection kits, including viral transport media such as saline and PBS solutions for extended viral transport, as well as rapid antigen tests for COVID-19. It also produces a COVID-19 neutralization antibody rapid test, a TB antigen detection device (MPT64), and a group B streptococcus (GBS) screening broth for microbiological use.

These devices are classified as Class A and Class I medical devices, with some designated as in vitro diagnostic (IVD) general devices and IVD self-testing products. They are listed in regulatory databases including EUDAMED, the FDA’s 510(k) and UDI registries, indicating compliance with European and US requirements. The company is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
China
Address
No. 139, 10th Street(East), Hangzhou Economic & Technological Development Zone, Hangzhou, China
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Jianping Zhu
EUDAMED SRN
CN-MF-000013495
FDA FEI Number
—
DUNS Number
547938709

Catalogue (121)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Extended ViralTrans M221015
EUDAMED
Class AActive
Enterovirus 71 IgM Rapid Test P231115
EUDAMED
IVD GeneralActive
KaiBiLi COVID-19 Antigen Pro P211138
EUDAMED
IVD GeneralActive
BacTrans Swabs M221111
EUDAMED
Class IActive
EBNA IgG Rapid Test P231117
EUDAMED
IVD GeneralActive
COVID-l9 Antigen Rapid Test Device P211134
EUDAMED
IVD GeneralActive
BacTrans Swabs M221107
EUDAMED
Class IActive
Extended ViralTrans M221008
EUDAMEDFDA UDI
Class AActive
BacTrans Swabs M221103
EUDAMED
Class IActive
HPIVs Antigen Rapid Test P213114
EUDAMED
IVD GeneralActive
Extended ViralTrans M221013
EUDAMED
Class AActive
Extended ViralTrans M221012
EUDAMEDFDA UDI
Class AActive
H. pylori Antibody Rapid Test P221103
EUDAMED
IVD GeneralActive
EZER NAAT SARS-CoV-2 real-time RT-PCR Kit N211101
EUDAMED
IVD GeneralActive
EZER Flu & COVID-19 Antigen Duo Rapid Test P213107
EUDAMED
IVD devices for self-testingActive
Dengue IgG/IgM Rapid Test Device P231106
EUDAMED
IVD GeneralActive
Strep B Antigen Rapid Test P281003
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae Antigen Rapid Test P211006
EUDAMED
IVD GeneralActive
Carbapenemase Rapid Test P261102
EUDAMED
IVD GeneralActive
Extended ViralTrans M221006
EUDAMEDFDA UDI
Class AActive
Extended NTM M221117
EUDAMED
Class AActive

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