FDA Registration
Active
🇺🇸 United States
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)
Reg #: 3004153557
·
FEI: 3004153557
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Menarini Silicon Biosystems Inc.
- Registration Number
- 3004153557
- FEI Number
- 3004153557
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3401 Masons Mill road, Suite 100
- City
- Huntingdon Valley
- State
- PA
- ZIP
- 19006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103502
Owner / Operator
- Firm Name
- Menarini Silicon Biosystems Inc.
- Operator Number
- 10054393
- Address
- 3401 Masons Mill Road, Suite 100
- City
- Huntingdon Valley
- State
- PA
- Postal Code
- 19006
- Country
- US
- Correspondent
- Thomas Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Immunomagnetic, Circulating Cancer Cell, Enumeration | NQI | Class 2 | Immunology | No | 2017-04-06 |
Proprietary Names
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198