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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 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KaiBiLi Extended ViralTrans Saline | M221127 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans PBS | M221113 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans Saline | M221125 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans Saline | M221126 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans Saline | M221128 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans Saline | M221129 | FDA UDI | Class I | Active |
| KaiBiLi Extended ViralTrans PBS | M221114 | FDA UDI | Class I | Active |
| KaiBiLi COVID-19 Antigen Pro | P211138-5 | EUDAMED | IVD General | Active |
| KaiBiLi COVID-19 Antigen Neo | P211136 | EUDAMED | IVD General | Active |
| Tb Mpt64 | P211010 | EUDAMED | IVD General | Active |
| COVID-19 Neutralization Antibody Rapid Test | P231141 | EUDAMED | IVD General | Active |
| GBS Screen Broth | M131002 | EUDAMED | IVD General | Active |
| ADV Antigen Rapid Test Device | P212113 | EUDAMED | IVD General | Active |
| Flu A+B Antigen Rapid Test | P211002 | EUDAMED | IVD General | Active |
| H.pylori Antigen Rapid Test | P221007 | EUDAMED | IVD General | Active |
| CTX-M β-lactamases Rapid Test | P261104 | EUDAMED | IVD General | Active |
| Malaria Pf Antigen Rapid Test Device | P231107 | EUDAMED | IVD General | Active |
| COVID-19 IgG/IgM Rapid Test Device [EN] | P231133 | EUDAMED | IVD General | Active |
| ANTICHEK SARS-CoV-2 (COVID-19) Antigen Test | P211135 | EUDAMED | IVD General | Active |
| EBV-VCA IgG Rapid Test | P231116 | EUDAMED | IVD General | Active |
| Leptospira IgG/IgM Rapid Test | P231119 | EUDAMED | IVD General | Active |
| Dengue IgG/IgM/NS1 Combo Rapid Test Device | P231105 | EUDAMED | IVD General | Active |
| SP-10 Male Fertility Rapid Test | P281002 | EUDAMED | IVD General | Active |
| Filariasis IgG/IgM Rapid Test | P231120 | EUDAMED | IVD General | Active |
| Adenovirus Antigen Rapid Test | P211005 | EUDAMED | IVD General | Active |
| PCT/IL-6 Rapid Test (FIA) | P232102 | EUDAMED | IVD General | Active |
| Extended NTM | M221119 | EUDAMED | Class A | Active |
| Malaria Pf/Pv Antigen Rapid Test Device | P231108 | EUDAMED | IVD General | Active |
| Mycoplasma pneumoniae IgG/IgM Rapid Test | P231110 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221007 | EUDAMEDFDA UDI | Class A | Active |
| Flu A+B Antigen Rapid Test Device | P212102 | EUDAMED | IVD General | Active |
| KaiBiLi Extended ViralTrans | K231027 | FDA 510(k) | Class I | Active |
| Malaria Pf/Pan Antigen Rapid Test Device | P231109 | EUDAMED | IVD General | Active |
| Campylobacter Antigen Rapid Test | P221107 | EUDAMED | IVD General | Active |
| Extended NTM | M221118 | EUDAMED | Class A | Active |
| HSV 1/2 IgM Rapid Test | P231114 | EUDAMED | IVD General | Active |
| SARS-CoV-2 & Flu & RSV & ADV Antigen Combo Rapid Test | P211145 | EUDAMED | IVD General | Active |
| COVID-19 Total Antibody Rapid Test | P231140 | EUDAMED | IVD General | Active |
| HAV IgM Rapid Test | P231103 | EUDAMED | IVD General | Active |
| EZER COVID-19 Antigen Rapid Test | P213104 | EUDAMED | IVD devices for self-testing | Active |
| Norovirus Antigen Rapid Test Device | P221101 | EUDAMED | IVD General | Active |
| BacTrans Swabs | M221104 | EUDAMED | Class I | Active |
| Extended ViralTrans | M221010 | EUDAMEDFDA UDI | Class A | Active |
| OXA-23 Carbapenemase Rapid Test | P261103 | EUDAMED | IVD General | Active |
| Extended NTM | M221121 | EUDAMED | Class A | Active |
| BacTrans Swabs | M221108 | EUDAMED | Class I | Active |
| Candida albicans /Gardnerella vaginalis/Trichomonas vaginalis antigen Combo Rapid Test | P271102 | EUDAMED | IVD General | Active |
| BacTrans Swabs | M221101 | EUDAMED | Class I | Active |
| BacTrans swabs | M221102 | EUDAMED | Class I | Active |
| Sampling Swab | A111114 | EUDAMED | Class I | Active |
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