FDA Registration
Active
🇨🇳 China
Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)
Reg #: 3014655875
·
FEI: 3014655875
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GENOBIO PHARMACEUTICAL CO., LTD.
- Registration Number
- 3014655875
- FEI Number
- 3014655875
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area,Binhai New Area
- City
- Tianjin
- Country
- CN
Owner / Operator
- Firm Name
- Genobio Pharmaceutical Co., Ltd.
- Operator Number
- 10066045
- Address
- 2-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area,Binhai New Area
- City
- Tianjin
- State
- CN-TJ
- Postal Code
- 300480
- Country
- CN
- Correspondent
- Zixi He
US Agent
- Business Name
- JOYSUN USA LLC
- Contact Name
- Weian Huang
- Address
- 15210 Cambridge St
- City
- Tustin
- State
- CA
- ZIP
- 92782
- Country
- US
- [email protected]
- Phone
- 949 4624543
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, Latex Agglutination, Cryptococcus Neoformans | GMD | Class 2 | Microbiology | No | 2020-03-31 |
Proprietary Names
Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device