FDA device listing
Hemolysate Reagent,Hemolysate Reagent (Powder),Hemolysate Reagent without KCN
FDA device listing 1586039372 · HELENA LABORATORIES, CORP.
Key facts
| Proprietary names | Hemolysate Reagent,Hemolysate Reagent (Powder),Hemolysate Reagent without KCN |
|---|---|
| Owner/operator | HELENA LABORATORIES, CORP. |
| Owner/operator number | 1618982 |
| Product codes | GKA |
| Device names | GKA - Abnormal Hemoglobin Quantitation |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7415 |
| 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
- 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