FDA device listing
IFA Mosaic: Coxsackie virus A Types (IgG),IFA Mosaic: Coxsackie virus B Types (IgG),IFA Mosaic: Coxsackie virus…
FDA device listing 1324938835 · EUROIMMUN Medizinische Labordiagnostika AG
Key facts
| Proprietary names | IFA Mosaic: Coxsackie virus A Types (IgG),IFA Mosaic: Coxsackie virus B Types (IgG),IFA Mosaic: Coxsackie virus (IgG),IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG) |
|---|---|
| Owner/operator | EUROIMMUN Medizinische Labordiagnostika AG |
| Owner/operator number | 10025212 |
| Product codes | GNM |
| Device names | GNM - Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.3145 |
| 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
- 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