FDA Registration
Active
🇨🇳 China
Urine Microalbumin Kit (Latex Immunoturbidimetric Method)
Reg #: 3013352333
·
FEI: 3013352333
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI KEHUA BIO-ENGINEERING CO., LTD.
- Registration Number
- 3013352333
- FEI Number
- 3013352333
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1189 North Qinzhou Road, 200233 Shanghai, PEOPLE'S REPUBLIC OF CHINA
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Kehua Bio-engineering Co., Ltd.
- Operator Number
- 10089583
- Address
- 1189 North Qinzhou Road, 200233 Shanghai, PEOPLE'S REPUBLIC OF CHINA
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200233
- Country
- CN
- Correspondent
- Amanda Shang
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St WU
- Address
- 1942 Broadway St., STE 314C, Boulder, CO, 80302, USA
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2023-12-22 |
Proprietary Names
Urine Microalbumin Kit (Latex Immunoturbidimetric Method)
Urine Microalbumin Kit (Immunoturbidimetric Assay)
Establishment Types
Manufacture Medical Device