FDA device listing
CS triCHROME CD8-FITC/CD4-RD1/CD3-PC5,CS triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5,CYTO-COMP REAGENT
FDA device listing 1958693108 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | CS triCHROME CD8-FITC/CD4-RD1/CD3-PC5,CS triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5,CYTO-COMP REAGENT |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K964618 |
| Product codes | GKZ |
| Device names | GKZ - Counter, Differential Cell |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5220 |
| Review panels | Hematology |
| Registered establishments | BECKMAN COULTER, INC. |
| Establishment registrations | 1017835, 1061932 |
| FEI numbers | 1017835, 3000203293 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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