FDA device listing
Lyme ELISA (IgG/IgM)
FDA device listing 1546275921 · EUROIMMUN Medizinische Labordiagnostika AG
Key facts
| Proprietary names | Lyme ELISA (IgG/IgM) |
|---|---|
| Owner/operator | EUROIMMUN Medizinische Labordiagnostika AG |
| Owner/operator number | 10025212 |
| Premarket submissions | K142038 |
| Product codes | LSR |
| Device names | LSR - Reagent, Borrelia Serological Reagent |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3830 |
| Review panels | Microbiology |
| 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
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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