FDA Registration
Active
🇩🇪 Germany
Transferrin (LN 1E04-21, 1E04-22, 1E04-42)
Reg #: 3002809144
·
FEI: 3002809144
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT GmbH
- Registration Number
- 3002809144
- FEI Number
- 3002809144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Planck-Ring 2
- City
- Wiesbaden Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K983167
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Sara Qadri
- Address
- 675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 6680142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2007-12-07 |
Proprietary Names
Transferrin (LN 1E04-21, 1E04-22, 1E04-42)
Alinity c Transferrin Reagent Kit (LN 08P3820)
Transferrin (Alinity c, LN 08P3824)
Transferrin (ARCHITECT, LN 01E0424 and 01E0444)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device