FDA Registration
Active
🇺🇸 United States
MEDTOX DIAGNOSTICS, INC.
Reg #: 3004175381
·
FEI: 3004175381
·
Expires 2026
Products
18
Proprietary Names
13
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- MEDTOX DIAGNOSTICS, INC.
- Registration Number
- 3004175381
- FEI Number
- 3004175381
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1640 NOVA LANE
- City
- BURLINGTON
- State
- NC
- ZIP
- 27215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992111
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, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2008-02-12 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2011-01-24 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2011-01-24 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2011-01-24 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2008-02-19 |
| 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, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2008-12-15 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2008-12-15 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2008-02-12 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2025-12-05 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2026-05-18 |
| High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Class 2 | Clinical Toxicology | No | 2009-12-14 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2008-02-12 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2008-02-12 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2009-03-09 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2018-12-14 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2025-12-05 |
Proprietary Names
PROFILE-IIA
PROFILE-II
EZ-SCREEN
VERDICT-II
MEDTOX OXYCODONE
PROFILE-II ER
Labcorp Comfort Draw
PROFILE-V MEDTOXScan
PROFILE-V
MEDTOXScan
P-V MEDTOXScan
MEDTOX
Labcorp
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only