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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 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EZER COVID-19 Antigen Rapid Test | P213108 | EUDAMED | IVD devices for self-testing | Active |
| BacTrans Swabs | M221110 | EUDAMED | Class I | Active |
| Strep A Antigen Rapid Test | P211116 | EUDAMED | IVD General | Active |
| GBS Screen Broth | M131001 | EUDAMED | IVD General | Active |
| Rotavirus Antigen Rapid Test Device | P221102 | EUDAMED | IVD General | Active |
| SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test | P211144 | EUDAMED | IVD General | Active |
| CRP/MxA Combo Rapid Test | P231123 | EUDAMED | IVD General | Active |
| Salmonella Typhi IgG/IgM Rapid Test | P231118 | EUDAMED | IVD General | Active |
| KL-6 Rapid Test (FIA) | P232103 | EUDAMED | IVD General | Active |
| Human metapneumovirus Antigen Rapid Test | P213115 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221001 | EUDAMEDFDA UDI | Class A | Active |
| Rotavirus / ADV Antigen Rapid Test Device | P221104 | EUDAMED | IVD General | Active |
| Legionella Antigen Rapid Test Device | P241110 | EUDAMED | IVD General | Active |
| HEV IgM Rapid Test | P231113 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221009 | EUDAMEDFDA UDI | Class A | Active |
| KaiBiLi COVID-19 Antigen Saliva Test | P211142 | EUDAMED | IVD General | Active |
| Dengue NS1 Rapid Test Device | P231104 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221011 | EUDAMEDFDA UDI | Class A | Active |
| Astrovirus Antigen Rapid Test | P221112 | EUDAMED | IVD General | Active |
| Extended NTM | M221124 | EUDAMED | Class A | Active |
| Sampling Swab | A111113 | EUDAMED | Class I | Active |
| MMP-3 Rapid Test (FIA) | P232101 | EUDAMED | IVD General | Active |
| Flu & COVID-19 Antigen Combo Rapid Test | P213110 | EUDAMED | IVD General | Active |
| C. difficile GDH & Toxin A+B Combo Rapid Test | P221115 | EUDAMED | IVD General | Active |
| Cryptosporidium Antigen Rapid Test | P221111 | EUDAMED | IVD General | Active |
| C. difficile GDH & Toxin A/B Combo Rapid Test | P221109 | EUDAMED | IVD General | Active |
| Strep. pneumoniae Antigen Rapid Test | P241108 | EUDAMED | IVD General | Active |
| BacTrans Swabs | M221109 | EUDAMED | Class I | Active |
| BloodPrime | M443106 | EUDAMED | Class A | Active |
| Sampling Swab | A111116 | EUDAMED | Class I | Active |
| Extended NTM | M221123 | EUDAMED | Class A | Active |
| Vibrio cholerae O1/O139 Antigen Rapid Test | P221108 | EUDAMED | IVD General | Active |
| Sampling Swab | A111117 | EUDAMED | Class I | Active |
| Salmonella Typhi Antigen Rapid Test | P221106 | EUDAMED | IVD General | Active |
| Extended NTM | M221122 | EUDAMED | Class A | Active |
| RSV Antigen Rapid Test Device | P212112 | EUDAMED | IVD General | Active |
| B. pertussis Antigen Rapid Test | P211106 | EUDAMED | IVD General | Active |
| Extended NTM | M221120 | EUDAMED | Class A | Active |
| BacTrans Swabs | M221105 | EUDAMED | Class I | Active |
| Sampling Swab | A111112 | EUDAMED | Class I | Active |
| Respiratory Syncytial Virus Antigen Rapid Test | P211004 | EUDAMED | IVD General | Active |
| Calprotectin Rapid Test | P221105 | EUDAMED | IVD General | Active |
| MCR-1 Enzyme Rapid Test | P261105 | EUDAMED | IVD General | Active |
| Extended ViralTrans | M221007b | EUDAMED | Class A | Active |
| KaiBiLi COVID-19 Antigen | P211139 | EUDAMED | IVD General | Active |
| Tb Mpt64 | P211009 | EUDAMED | IVD General | Active |
| Shigella Antigen Rapid Test | P221110 | EUDAMED | IVD General | Active |
| COVID-19 Neutralization Ab+ Rapid Test | P231145 | EUDAMED | IVD General | Active |
| ADV/RSV Antigen Rapid Test Device | P212106 | EUDAMED | IVD General | Active |
| Treponema Pallidum Antibody Rapid Test | P231111 | EUDAMED | IVD General | Active |
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