FDA Registration
Active
🇺🇸 United States
P-V MEDTOXScan
Reg #: 3004175381
·
FEI: 3004175381
·
Expires 2025
Products
10
Proprietary Names
5
Establishment Types
1
Classifications
10
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
- K080635
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, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2009-03-09 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2009-03-09 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2009-03-09 |
Proprietary Names
P-V MEDTOXScan
PROFILE-V
PROFILE-V MEDTOXScan
MEDTOX
MEDTOXScan
Establishment Types
Manufacture Medical Device