FDA Registration
Active
🇺🇸 United States
T-Cup
Reg #: 3007606081
·
FEI: 3007606081
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- WONDFO USA CO., LTD.
- Registration Number
- 3007606081
- FEI Number
- 3007606081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 890 Remington Blvd
- City
- Bolingbrook
- State
- IL
- ZIP
- 60440
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130665
Owner / Operator
- Firm Name
- Wondfo USA Co., Ltd.
- Operator Number
- 10028951
- Address
- 890 REMINGTON BLVD
- City
- Bolingbrook
- State
- IL
- Postal Code
- 60440
- Country
- US
- Correspondent
- Kunyuan Mao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2013-12-04 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2013-12-04 |
Proprietary Names
T-Cup
Prime Screen
Wondfo
Establishment Types
Complaint File Establishment per 21 CFR 820.198