FDA Registration
Active
🇩🇪 Germany
Lyme ELISA (IgG/IgM)
Reg #: 3007361513
·
FEI: 3007361513
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Registration Number
- 3007361513
- FEI Number
- 3007361513
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- EUROIMMUN AG, Werkstrasse 1
- City
- Dassow Mecklenburg-Western Pomerania
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K142038
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 |
|---|---|---|---|---|---|
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2015-05-05 |
Proprietary Names
Lyme ELISA (IgG/IgM)
Establishment Types
Manufacture Medical Device