FDA Registration
Active
🇩🇰 Denmark
HER2 IQFISH pharmDx
Reg #: 3013059683
·
FEI: 3013059683
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ATSI Logistics Center ApS
- Registration Number
- 3013059683
- FEI Number
- 3013059683
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 42 PRODUKTIONSVEJ, --
- City
- GLOSTRUP Hovedstaden
- Country
- DK
Regulatory Submissions
- PMA Number
- P040005
Owner / Operator
- Firm Name
- Agilent Technologies, Inc
- Operator Number
- 10038794
- Address
- 5301 Stevens Creek Blvd
- City
- Santa Clara
- State
- CA
- Postal Code
- 95051
- Country
- US
- Correspondent
- Widad Ghaben
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Her-2/Neu, Nucleic Acid Or Serum | MVD | Class 3 | Unknown | No | 2020-12-16 |
Proprietary Names
HER2 IQFISH pharmDx
Establishment Types
Export Device to the United States But Perform No Other Operation on Device