FDA Registration
Active
🇨🇳 China
GENRUI BIOTECH INC
Reg #: 3014100717
·
FEI: 3014100717
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- GENRUI BIOTECH INC
- Registration Number
- 3014100717
- FEI Number
- 3014100717
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4-10F, Building 3, Geya Technology Park, Guangming District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Genrui Biotech Inc
- Operator Number
- 10056079
- Address
- 4-10 Floors, Building 3, Geya Technology Park, Guangming District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluorometer | JZT | Class 1 | Immunology | No | 2025-05-30 |
| Nephelometer | JZW | Class 1 | Immunology | No | 2017-11-03 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2018-05-10 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2020-08-19 |
Proprietary Names
Handheld Dry Fluorescence Immunoassay Analyzer FA20;Quantitative Immunoassay Analyzer FA30, FA31
Fully-auto Specific Protein Analyzer PA480S, PA480,PA240S, PA240
Genrui Specific Protein Analyzer PA50/54
Genrui Specific Protein Analyzer PA120
Genrui Specific Protein Analyzer PA200
Quantitative Immunoassay Analyzer FA50, FA51, FA52, FA53, FA54
Fully-Auto Nucleic Acid Extraction Instrumen Nucleic Acid Extraction Kit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device