FDA device listing
QuickGel Acid Hemoglobin Kit,SPIFE 4000 Acid Hemoglobin Kit,SPIFE Acid Hemoglobin,SPIFE Nexus Acid…
FDA device listing 1601814219 · HELENA LABORATORIES, CORP.
Key facts
| Proprietary names | QuickGel Acid Hemoglobin Kit,SPIFE 4000 Acid Hemoglobin Kit,SPIFE Acid Hemoglobin,SPIFE Nexus Acid Hemoglobin,SPIFE/QuickGel Acid Hemoglobin Kit |
|---|---|
| Owner/operator | HELENA LABORATORIES, CORP. |
| Owner/operator number | 1618982 |
| Premarket submissions | K992199 |
| Product codes | JBD |
| Device names | JBD - System, Analysis, Electrophoretic Hemoglobin |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7440 |
| Review panels | Hematology |
| Registered establishments | HELENA LABORATORIES, CORP. |
| Establishment registrations | 1618982 |
| FEI numbers | 1618982 |
| 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