FDA Registration
Active
🇨🇳 China
Tanner Scientific Inc. BluRapids Multi-Drug Urine Test Panel
Reg #: 3004635103
·
FEI: 3004635103
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Registration Number
- 3004635103
- FEI Number
- 3004635103
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.8 Lizhishan Road, Science City, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133968
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, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2014-05-26 |
Proprietary Names
Tanner Scientific Inc. BluRapids Multi-Drug Urine Test Panel
Easy At Home Medical LLC Easy@Home Multi-Drug Urine Test Cup
Mercedes Medical BluRapids Concise Multi-Drug Test Cup
Wondfo USA Co. Ltd CLIA Screen Multi-Drug Urine Test Cup
T-Cup Compact Multi-Drug Urine Test Cup
Magenta Technology Partners LLC, Magenta Multiple Panel Urine Dip Card
Tanner Scientific Inc. BluRapids Multi-Drug Urine Test Cup
Micro Distributing II Ltd. STATCUPII One Step Drug Test Cup
Mercedes Medical BluRapids Concise Multi-Drug Test Panel
Wondfo Multi-Drug Test Cup,Wondfo Multi-Drug Test Panel
Mercedes Medical BluRapids Concise Multi-Drug Test Panel (Dip Card Format)
Easy At Home Medical LLC Easy@Home Multi-Drug Urine Test Panel
Prime Screen Multi-Drug Test Panel
Jant Pharmacal Corporation Accutest Multi-Drug Urine Test Panel
Jant Pharmacal Corporation Accutest Multi-Drug Urine Test Cup
Alere Toxicology Services Alere iCup DxPro2 Multi-Drug Urine Test Cup
Clarity Diagnostics LLC. Clarity CLIA Waived Multi-Drug Urine Test Cup
Clarity Diagnostics LLC. Clarity CLIA Waived Multi-Drug Urine Test Panel
Jant Pharmacal Corporation Accutest Multi-Drug Urine Test Panel (Dip Card Format)
Easy Healthcare Corporation Areta Drug Test Cup
Micro Distributing II Ltd. STATDIP One-Step Multi Drug Urine Test Panel
Micro Distributing II Ltd. FASTEST LABS One Step Drug Test Cup
Wondfo USA Co. Ltd CLIA Screen Multi-Drug Urine Test Panel
Biotech Screening LLC Corrections Cup Multi-Drug Urine Test Cup
T-Cup Multi-Drug Urine Test Cup
Alere Toxicology Services Alere iCup Rx Multi-Drug Urine Test Cup
Establishment Types
Manufacture Medical Device