FDA Registration
Active
🇩🇪 Germany
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Reg #: 3003268355
·
FEI: 3003268355
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
- Registration Number
- 3003268355
- FEI Number
- 3003268355
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- EUROIMMUN AG, Seekamp 31
- City
- Luebeck Schleswig-Holstein
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K113439
Owner / Operator
- Firm Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Operator Number
- 10025212
- Address
- EUROIMMUN AG, Seekamp 31
- City
- Luebeck
- State
- Schleswig-Holstein
- Postal Code
- D-23560
- Country
- DE
- Correspondent
- Stephan Maihold
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Autoantibodies, Nuclear Pore Glycoprotein Gp210 | NRI | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | NBS | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | NIY | Class 2 | Immunology | No | 2013-04-17 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2013-04-17 |
| Autoantibodies, Nuclear Body Protein, Sp100 | NUM | Class 2 | Immunology | No | 2013-04-17 |
Proprietary Names
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
Establishment Types
Manufacture Medical Device