FDA Registration
Active
🇺🇸 United States
Saliva Alcohol Strip
Reg #: 2060833
·
FEI: 3001452245
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K111206
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 |
|---|---|---|---|---|---|
| Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | DIC | Class 2 | Clinical Toxicology | No | 2015-03-24 |
Proprietary Names
Saliva Alcohol Strip
Establishment Types
Repack or Relabel Medical Device