FDA Registration
Active
🇮🇹 Italy
Alinity c CRP Vario Reagent Kit
Reg #: 9681753
·
FEI: 3000303338
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SENTINEL CH. SPA
- Registration Number
- 9681753
- FEI Number
- 3000303338
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA ROBERT KOCH, 2
- City
- MILANO
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K192118
Owner / Operator
- Firm Name
- SENTINEL CH. SpA
- Operator Number
- 9025279
- Address
- Via Robert Koch, 2
- City
- Milan
- State
- Milano
- Postal Code
- 20152
- Country
- IT
US Agent
- Business Name
- Diagnostic Oncology CRO, LLC
- Contact Name
- Robert McNamee
- Address
- 1 Jacks Hill Rd Ste 1ab
- City
- Oxford
- State
- CT
- ZIP
- 06478
- Country
- US
- [email protected]
- Phone
- 203 5989105
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2019-12-23 |
Proprietary Names
Alinity c CRP Vario Reagent Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device