FDA Registration
Active
🇺🇸 United States
icONE
Reg #: 3030714692
·
FEI: 3030714692
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AB DIGIHEALTH
- Registration Number
- 3030714692
- FEI Number
- 3030714692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Harvard Business Services, Inc, 16192 Coastal Hwy
- City
- Lewes
- State
- DE
- ZIP
- 19958
- Country
- US
Owner / Operator
- Firm Name
- AB DigiHealth
- Operator Number
- 10090464
- Address
- Harvard Business Services, Inc, 16192 Coastal Hwy
- City
- Lewes
- State
- DE
- Postal Code
- 19958
- Country
- US
- Correspondent
- Frank Ong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2024-04-01 |
Proprietary Names
icONE
Establishment Types
Complaint File Establishment per 21 CFR 820.198