FDA Registration
Active
🇺🇸 United States
T-Cube Oral Fluid Drug Test
Reg #: 3007606081
·
FEI: 3007606081
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2020-12-24 |
Proprietary Names
T-Cube Oral Fluid Drug Test
UScreen
iScreen Multi-Drug Urine Test Cup
SAFElife T-Square Multi-Drug Oral Fluid Test
PRIME SCREEN® One Step Multi-Drug Oral Fluid Test
iSCREEN ORAL FLUID TEST DRUG SCREEN CUBE
STATSWAB® III Oral Fluid Drug Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198