FDA Registration
Active
🇮🇹 Italy
QUANTA Lite h-tTG IgG ELISA
Reg #: 3012348571
·
FEI: 3012348571
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY SPA
- Registration Number
- 3012348571
- FEI Number
- 3012348571
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Leonardo da Vinci, 36
- City
- Roncello Lombardy
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K011570
Owner / Operator
- Firm Name
- Instrumentation Laboratory SpA
- Operator Number
- 10082968
- Address
- Viale Monza 338
- City
- Milan
- State
- Lombardy
- Postal Code
- 20128
- Country
- IT
- Correspondent
- Natale Bova
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2024-12-05 |
Proprietary Names
QUANTA Lite h-tTG IgG ELISA
QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase)
QUANTA Lite h-tTG IgG ELISA Bulk Pack
Establishment Types
Export Device to the United States But Perform No Other Operation on Device