FDA Registration
Active
🇺🇸 United States
OralTox Oral Fluid Drug Test
Reg #: 3016637761
·
FEI: 3016637761
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Premier Biotech, LLC
- Registration Number
- 3016637761
- FEI Number
- 3016637761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7451 Trade Street, Suite B
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171403
Owner / Operator
- Firm Name
- Premier Biotech, LLC
- Operator Number
- 10057135
- Address
- 725 Kasota Avenue SE
- City
- Minneapolis
- State
- MN
- Postal Code
- 55414
- Country
- US
- Correspondent
- Matthew Michalik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2018-03-09 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2018-03-09 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2018-03-09 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2018-03-09 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2018-03-09 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2018-03-09 |
Proprietary Names
OralTox Oral Fluid Drug Test
Establishment Types
Repack or Relabel Medical Device