FDA Registration
Active
🇺🇸 United States
Premier Biotech, LLC
Reg #: 3010800486
·
FEI: 3010800486
·
Expires 2026
Products
23
Proprietary Names
8
Establishment Types
3
Classifications
23
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Registration Details
- Registration Name
- Premier Biotech, LLC
- Registration Number
- 3010800486
- FEI Number
- 3010800486
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 725 Kasota Ave SE
- City
- Minneapolis
- State
- MN
- ZIP
- 55414
- 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, Phencyclidine | LCM | Class U | Unknown | No | 2018-03-09 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | 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 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2018-09-24 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Codeine, Employment And Insurance Testing, Exempt | PVB | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2020-11-03 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2021-09-16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2021-09-10 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2024-07-11 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2024-07-11 |
Proprietary Names
OralTox Oral Fluid Drug Test
Premier OralTox
OralTox
O-Swab
OralToxWP
OT-Scan
Premier Bio-Dip
Premier Bio-Cup
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only