FDA Registration
Active
🇺🇸 United States
FastPack® IP Vitamin D Kit
Reg #: 2032087
·
FEI: 3003355251
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- QUALIGEN, INC.
- Registration Number
- 2032087
- FEI Number
- 3003355251
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2042 CORTE DEL NOGAL
- City
- CARLSBAD
- State
- CA
- ZIP
- 92011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123983
Owner / Operator
- Firm Name
- QUALIGEN, INC.
- Operator Number
- 9040045
- Address
- 2042 CORTE DEL NOGAL, --
- City
- Carlsbad
- State
- CA
- Postal Code
- 92011
- Country
- US
- Correspondent
- Scott A Doyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-12-17 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2013-12-17 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2013-12-17 |
Proprietary Names
FastPack® IP Vitamin D Kit
Establishment Types
Manufacture Medical Device