FDA Registration
Active
🇺🇸 United States
Premier Bio-Dip
Reg #: 3010800486
·
FEI: 3010800486
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Premier Biotech, LLC
- Registration Number
- 3010800486
- FEI Number
- 3010800486
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 725 Kasota Ave SE
- City
- Minneapolis
- State
- MN
- ZIP
- 55414
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122809
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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-07-11 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-07-11 |
Proprietary Names
Premier Bio-Dip
Premier Bio-Cup
Establishment Types
Complaint File Establishment per 21 CFR 820.198