FDA device listing
IDS-iSYS Insulin like Growth Factor-I (IGF-I),IDS SDSpeed Calc
FDA device listing 1248411688 · EUROIMMUN US Inc.
Key facts
| Proprietary names | IDS-iSYS Insulin like Growth Factor-I (IGF-I),IDS SDSpeed Calc |
|---|---|
| Owner/operator | EUROIMMUN US Inc. |
| Owner/operator number | 10025673 |
| Product codes | OAM |
| Device names | OAM - Immunoassay, Insulin-Like Growth Factor Binding Protein-1 |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1550 |
| Review panels | Clinical Chemistry |
| Registered establishments | EUROIMMUN US INC. |
| Establishment registrations | 3007118747 |
| FEI numbers | 3007118747 |
| Establishment operations | Complaint File Establishment |
| 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