FDA Registration
Active
🇺🇸 United States
PROFILE-II
Reg #: 3004175381
·
FEI: 3004175381
·
Expires 2025
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MEDTOX DIAGNOSTICS, INC.
- Registration Number
- 3004175381
- FEI Number
- 3004175381
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1640 NOVA LANE
- City
- BURLINGTON
- State
- NC
- ZIP
- 27215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010564
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, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2008-12-15 |
Proprietary Names
PROFILE-II
PROFILE-IIA
VERDICT-II
Establishment Types
Manufacture Medical Device