FDA device listing
Cascade POC c-ACT Level 1 Control,Cascade POC c-ACT Level 2 Control,Cascade POC c-ACT Test Controls
FDA device listing 1467110352 · HELENA LABORATORIES, CORP.
Key facts
| Proprietary names | Cascade POC c-ACT Level 1 Control,Cascade POC c-ACT Level 2 Control,Cascade POC c-ACT Test Controls |
|---|---|
| Owner/operator | HELENA LABORATORIES, CORP. |
| Owner/operator number | 1618982 |
| Product codes | GGC, GGN, GIZ, JJX |
| Device names | GGC - Control, Plasma, Abnormal, GGN - Plasma, Coagulation Control, GIZ - Plasma, Control, Normal, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1660, 864.5425 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | HELENA LABORATORIES, CORP. |
| Establishment registrations | 1618982 |
| FEI numbers | 1618982 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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