FDA Registration
Active
🇺🇸 United States
Multi-Drugs of Abuse Urine Cup Test
Reg #: 2060833
·
FEI: 3001452245
·
Expires 2025
Products
12
Proprietary Names
14
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Registration Number
- 2060833
- FEI Number
- 3001452245
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13200 GREGG ST.
- City
- POWAY
- State
- CA
- ZIP
- 92064
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063545
Owner / Operator
- Firm Name
- ALFA SCIENTIFIC DESIGNS, INC.
- Operator Number
- 9034872
- Address
- 13200 GREGG ST., --
- City
- Poway
- State
- CA
- Postal Code
- 92064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| NCI | No | 2007-12-05 | |||
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2007-12-05 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2007-12-05 |
Proprietary Names
Multi-Drugs of Abuse Urine Cup Test
Oxycodone (100) Urine Test (Cassette/Dip Strip)
Instant-View Cocaine (150) Urine Test (Cassette/Dip Strip)
Instant-View Amphetamine (300) Urine Test (Cassette/Dip Strip)
Instant-View Oxycodone (100) Urine Test (Cassette/Dip Strip)
Instant-View Multi-Drugs of Abuse Urine Panel Test
Amphetamine (300) Urine Test (Cassette/Dip Strip)
Instant-View Oxycodone (300) Urine Test (Cassette/Dip Strip)
Instant-View Methamphetamine (300) Urine Test (Cassette/Dip Strip)
Oxycodone (300) Urine Test (Cassette/Dip Strip)
Instant-View Multi-Drugs of Abuse Urine Cup Test
Methamphetamine (300) Urine Test (Cassette/Dip Strip)
Cocaine (150) Urine Test (Cassette/Dip Strip)
Multi-Drugs of Abuse Urine Panel Test
Establishment Types
Manufacture Medical Device