FDA Registration
Active
🇩🇪 Germany
Adjustment solution
Reg #: 3003268355
·
FEI: 3003268355
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
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
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 |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2022-08-24 |
Proprietary Names
Adjustment solution
Secondary reagents immunoblot (IgM)
EUROArray wash buffer set
Secondary reagents immunoblot (IgG)
PBS (IIFT)
Sample buffer 2, Crithidia luciliae sensitive (IFA)
PBS-Tween (IFA)
ELISA enzyme conjugate, anti-human IgA
ELISA chromogen/substrate solution
TITERPLANE set for the incubation of slides with 50 fields
ELISA Stop solution
ELISA sample buffer
Sample buffer (IIFT)
FITC-labelled anti-human IgA
FITC-labelled anti-human IgG
WASH REAGENT 2
Establishment Types
Manufacture Medical Device