FDA Registration
Active
🇩🇪 Germany
ARCHITECT FSH Reagent Kit (LN 7K75-25, 7K75-35)
Reg #: 3002809144
·
FEI: 3002809144
·
Expires 2025
Products
1
Proprietary Names
2
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
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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 1999-02-12 |
Proprietary Names
ARCHITECT FSH Reagent Kit (LN 7K75-25, 7K75-35)
Alinity i FSH Reagent Kit (LN 07P4920, 07P4930)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device