FDA Registration
Active
🇺🇸 United States
PROFILE-II ER
Reg #: 1050155
·
FEI: 1050155
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTOX DIAGNOSTICS, INC.
- Registration Number
- 1050155
- FEI Number
- 1050155
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1238 Anthony Rd
- City
- BURLINGTON
- State
- NC
- ZIP
- 27215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020787
Owner / Operator
- Firm Name
- MEDTOX DIAGNOSTICS, INC.
- Operator Number
- 1050155
- Address
- 1238 ANTHONY RD., --
- City
- Burlington
- State
- NC
- Postal Code
- 27215
- Country
- US
- Correspondent
- ELIZABETH E BROCK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2008-02-12 |
Proprietary Names
PROFILE-II ER
PROFILE-IIA
EZ-SCREEN
Establishment Types
Manufacture Medical Device