FDA Registration
Active
🇨🇳 China
Micro Distributing II Ltd. FASTEST LABS Propoxyphene Urine Test
Reg #: 3023322455
·
FEI: 3023322455
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Registration Number
- 3023322455
- FEI Number
- 3023322455
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 268, Shenzhou Road, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152495
Owner / Operator
- Firm Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Operator Number
- 9064561
- Address
- No.8 lizhishan Road, Science City, Huangpu District, 510663
- City
- GUANGZHOU
- State
- Guangdong
- Postal Code
- 510663
- Country
- CN
- Correspondent
- Jihua - Wang
US Agent
- Business Name
- LSI International Inc.
- Contact Name
- Joe Shia
- Address
- 504 East Diamond Ave., Suite I
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 5057880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2016-03-09 |
Proprietary Names
Micro Distributing II Ltd. FASTEST LABS Propoxyphene Urine Test
Jant Pharmacal Corporation Accutest Propoxyphene Urine Test Cup
Guangzhou Wondfo Biotech Co. Ltd. Wondfo Propoxyphene Urine Test (DipCard)
Micro Distributing II Ltd. FASTEST LABS Propoxyphene Urine Test Cup
Guangzhou Wondfo Biotech Co. Ltd. Wondfo Propoxyphene Urine Test (Cup)
Micro Distributing II Ltd STATDIP Propoxyphene Urine Test
Jant Pharmacal Corporation Accutest Propoxyphene Urine Test
Micro Distributing II Ltd STATCUP II Propoxyphene Urine Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198