FDA Registration
Active
🇨🇳 China
Wondfo Multi-Drug Urine Test Panel (Dip Card Format)
Reg #: 3004635103
·
FEI: 3004635103
·
Expires 2025
Products
10
Proprietary Names
14
Establishment Types
1
Classifications
10
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
- K122904
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, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2013-08-06 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2013-08-06 |
Proprietary Names
Wondfo Multi-Drug Urine Test Panel (Dip Card Format)
Wondfo Multi-Drug Urine Test Cup (Cup Format)
STAT CUP One Step Drug TEST Cup (Cup Format)
Drug of Abuse Card
UScreen Drugs of Abuse Dip Card
Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel
Instant Drug Test Cup
UScreen Drugs of Abuse Cup
Biotech Screening Correction Cup (Cup Format)
Biotech Screening Correction Cup
STAT DIP One Step Multi Drug Test Panel (Dip Card Format)
INSTA-SCREEN Multi-Drug Urine Test Panel
AIT Laboratories Drug of Abuse Cup
AIT Laboratories Drug of Abuse Card
Establishment Types
Manufacture Medical Device