FDA device listing
hema-screen ER XCEL Enhanced Readability FOBT
FDA device listing 1250897304 · IMMUNOSTICS, INC.
Key facts
| Proprietary names | hema-screen ER XCEL Enhanced Readability FOBT |
|---|---|
| Owner/operator | IMMUNOSTICS, INC. |
| Owner/operator number | 2244821 |
| Premarket submissions | K163554 |
| Product codes | KHE |
| Device names | KHE - Reagent, Occult Blood |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.6550 |
| Review panels | Hematology |
| Registered establishments | IMMUNOSTICS, INC. |
| Establishment registrations | 2244821 |
| FEI numbers | 2244821 |
| Establishment operations | Complaint File Establishment, 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