FDA device listing
CELL-DYN 18 Plus Control (LN 07V07-06, 07V07-12),CELL-DYN 22 Plus Control (LN 07V09-06, 07V09-12)
FDA device listing 1740665371 · ABBOTT LABORATORIES
Key facts
| Proprietary names | CELL-DYN 18 Plus Control (LN 07V07-06, 07V07-12),CELL-DYN 22 Plus Control (LN 07V09-06, 07V09-12) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | GLQ |
| Device names | GLQ - Mixture, Control, White-Cell And Red-Cell Indices |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.8625 |
| Review panels | Hematology |
| Registered establishments | ABBOTT LABORATORIES |
| Establishment registrations | 3005333358, 3016438761 |
| FEI numbers | 3005333358, 3016438761 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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