FDA Registration
Active
🇮🇹 Italy
QUANTA Lite Gliadin IgA II ELISA
Reg #: 3012348571
·
FEI: 3012348571
·
Expires 2025
Products
1
Proprietary Names
2
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
- K052143
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 |
|---|---|---|---|---|---|
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2024-12-05 |
Proprietary Names
QUANTA Lite Gliadin IgA II ELISA
QUANTA Lite Gliadin IgA II ELISA Bulk Pack
Establishment Types
Export Device to the United States But Perform No Other Operation on Device