FDA Registration
Active
🇨🇳 China
INSTA-SCREEN Multi-Drug Urine Test Cup (Cup Format)
Reg #: 3004635103
·
FEI: 3004635103
·
Expires 2025
Products
8
Proprietary Names
15
Establishment Types
1
Classifications
8
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
- K130665
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 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2013-08-06 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2013-08-06 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-08-06 |
Proprietary Names
INSTA-SCREEN Multi-Drug Urine Test Cup (Cup Format)
STATCup3 One Step Drug Test Cup
Uscreen Drug of Abuse Cup
STATDIP One Step Multi-Drug Urine Test Panel
Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel
UScreen Drugs of Abuse Card
Easy@Home Multi-Drug Urine Test Cup
CLIA Screen Multi-Drug Urine Test Panel
Easy@Home Multi-Drug Urine Test Panel
AIT Laboratories Drug of Abuse Card
Drug of Abuse Card
CLIA Screen Multi-Drug Urine Test Cup
Biotech Screening Corrections Cup (Cup Format)
Instant Drug Test Cup
AIT Laboratories Drug of Abuse Cup
Establishment Types
Manufacture Medical Device