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Sign in to claim this brandShenzhen Genebiohealth Co., Ltd.
China·CN-MF-000046424
Last updated September 18, 2026
About
FOUNDED IN 2013, SHENZHEN, CHINA, IS BASED IN SHENZHEN, CHINA, AND FOCUSES ON IN VITRO DIAGNOSTICS AND HUMAN HEALTH, PROVIDING COMPLETE SOLUTIONS SUCH AS CANCER DIAGNOSIS, IMMEDIATE DETECTION AND ONCOLOGY AI INTELLIGENTLY PHASED。
Translated from the manufacturer's own website. Source
What Shenzhen Genebiohealth Co., Ltd. makes
Shenzhen Genebiohealth Co., Ltd. produces in vitro diagnostic (IVD) test kits for detecting specific antibodies and nucleic acids, including colloidal gold immunochromatographic assays for Epstein-Barr virus-related markers (EA-IgG, Zta-IgG, EBNA-IgA) and fluorescence PCR-based DNA methylation detection kits for cancer-related biomarkers like Reprimo and CABIN1. The company also offers RNA extraction kits and real-time PCR assay kits, such as the miR-92a assay, alongside disposable medical tubes for feces collection and storage.
The company’s diagnostic products fall under Class A and IVD General device classifications, with some listings recorded in the EU’s eudamed registry. The manufacturer is based in Shenzhen, China, and its devices are subject to regulatory oversight in accordance with applicable in vitro diagnostic regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- China
- Address
- Room 1801.Block A, Building7, Shenzhen International Innovation Valley, Dashi 1st Road Xili Community, Xili Street, Shenzhen, Guangdong Province, China
- Website
- www.genebiohealth.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Aiqing Chen
- EUDAMED SRN
- CN-MF-000046424
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable feces collection and storage tube | CRC030-g | EUDAMED | Class A | Active |
| EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay) | NPC010-100 | EUDAMED | IVD General | Active |
| RNA Extraction Kit | CRC021-C | EUDAMED | Class A | Active |
| Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay) | GC010-48 | EUDAMED | IVD General | Active |
| RNA Extraction Kit | CRC022-MB | EUDAMED | Class A | Active |
| EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay) | NPC010-50 | EUDAMED | IVD General | Active |
| miR-92a Assay Kit (RT-PCR) | CRC010 | EUDAMED | IVD General | Active |
| EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay) | NPC010-10 | EUDAMED | IVD General | Active |
| Disposable feces collection and storage tube | CRC030-x | EUDAMED | Class A | Active |
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