FDA Registration
Active
🇺🇸 United States
DrugConfirm Urine Drug Test Kits
Reg #: 3006048451
·
FEI: 3006048451
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Confirm Biosciences LLC
- Registration Number
- 3006048451
- FEI Number
- 3006048451
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8866 Cypress Court, Building E
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163704
Owner / Operator
- Firm Name
- Confirm Biosciences LLC
- Operator Number
- 9095540
- Address
- 8866 Cypress Court, Building E
- City
- San Diego
- State
- CA
- Postal Code
- 92154
- Country
- US
- Correspondent
- Albert - Berger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2021-08-30 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Propoxyphene | JXN | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2021-08-30 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2021-08-30 |
Proprietary Names
DrugConfirm Urine Drug Test Kits
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device