FDA Registration
Active
🇬🇧 United Kingdom
ABBOTT ARCHITECT Anti-CCP
Reg #: 8032314
·
FEI: 3002808140
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- AXIS-SHIELD DIAGNOSTICS, LTD.
- Registration Number
- 8032314
- FEI Number
- 3002808140
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LUNA PLACE, THE TECHNOLOGY PARK
- City
- DUNDEE Scotland
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K083868
Owner / Operator
- Firm Name
- AXIS-SHIELD DIAGNOSTICS, LTD.
- Operator Number
- 8032314
- Address
- LUNA PLACE, THE TECHNOLOGY PARK
- City
- DUNDEE, SCOTLAND
- State
- GB-NOTA
- Postal Code
- DD2 1XA
- Country
- GB
- Correspondent
- CLAIRE - DORA
US Agent
- Business Name
- Abbott Laboratories
- Contact Name
- Danial Kirmani
- Address
- Dept. Rx51/J55/Ms 6134, 100 Abbott Park Rd
- City
- North Chicago
- State
- IL
- ZIP
- 60064
- Country
- US
- [email protected]
- Phone
- 224 6686318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2009-10-20 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2009-10-20 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2009-10-20 |
Proprietary Names
ABBOTT ARCHITECT Anti-CCP
Establishment Types
Manufacture Medical Device