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Sign in to claim this brandHangzhou 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
- Website
- www.genesis-ivd.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jianping Zhu
- EUDAMED SRN
- CN-MF-000013495
- FDA FEI Number
- —
- DUNS Number
- 547938709
Catalogue (121)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Extended ViralTrans | M221015 | EUDAMED | Class A | Active |
| Enterovirus 71 IgM Rapid Test | P231115 | EUDAMED | IVD General | Active |
| KaiBiLi COVID-19 Antigen Pro | P211138 | EUDAMED | IVD General | Active |
| BacTrans Swabs | M221111 | EUDAMED | Class I | Active |
| EBNA IgG Rapid Test | P231117 | EUDAMED | IVD General | Active |
| COVID-l9 Antigen Rapid Test Device | P211134 | EUDAMED | IVD General | Active |
| BacTrans Swabs | M221107 | EUDAMED | Class I | Active |
| Extended ViralTrans | M221008 | EUDAMEDFDA UDI | Class A | Active |
| BacTrans Swabs | M221103 | EUDAMED | Class I | Active |
| HPIVs Antigen Rapid Test | P213114 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221013 | EUDAMED | Class A | Active |
| Extended ViralTrans | M221012 | EUDAMEDFDA UDI | Class A | Active |
| H. pylori Antibody Rapid Test | P221103 | EUDAMED | IVD General | Active |
| EZER NAAT SARS-CoV-2 real-time RT-PCR Kit | N211101 | EUDAMED | IVD General | Active |
| EZER Flu & COVID-19 Antigen Duo Rapid Test | P213107 | EUDAMED | IVD devices for self-testing | Active |
| Dengue IgG/IgM Rapid Test Device | P231106 | EUDAMED | IVD General | Active |
| Strep B Antigen Rapid Test | P281003 | EUDAMED | IVD General | Active |
| Mycoplasma pneumoniae Antigen Rapid Test | P211006 | EUDAMED | IVD General | Active |
| Carbapenemase Rapid Test | P261102 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221006 | EUDAMEDFDA UDI | Class A | Active |
| Extended NTM | M221117 | EUDAMED | Class A | Active |
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