FDA Registration
Active
🇺🇸 United States
Instant-View Multi-Drug Screen Urine Test
Reg #: 2060833
·
FEI: 3001452245
·
Expires 2025
Products
11
Proprietary Names
2
Establishment Types
3
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
- K022564
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 |
|---|---|---|---|---|---|
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2007-12-05 |
| Liquid Chromatography, Morphine | DPK | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | DOE | Class 2 | Clinical Toxicology | No | 2007-12-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2007-12-05 |
Proprietary Names
Instant-View Multi-Drug Screen Urine Test
Multi-Drug Screen Urine Test
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)