FDA device listing
Adjustment solution,Biotin-labelled anti-human IgG,ELISA chromogen/substrate solution,ELISA enzyme conjugate, anti-human…
FDA device listing 1611047909 · EUROIMMUN Medizinische Labordiagnostika AG
Key facts
| Proprietary names | Adjustment solution,Biotin-labelled anti-human IgG,ELISA chromogen/substrate solution,ELISA enzyme conjugate, anti-human IgA,ELISA sample buffer,ELISA Stop solution,ELISA wash buffer 10x conc.,EUROArray wash buffer set,EUROSORB (IFA),FITC-labelled anti-human IgA,FITC-labelled anti-human IgA with Evans Blue,FITC-labelled anti-human IgG,FITC-labelled anti-human IgG (primate absorbed),FITC-labelled… |
|---|---|
| Owner/operator | EUROIMMUN Medizinische Labordiagnostika AG |
| Owner/operator number | 10025212 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | EUROIMMUN Medizinische Labordiagnostika AG, EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |
| Establishment registrations | 3003268355, 3007361513 |
| FEI numbers | 3003268355, 3007361513 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database