FDA device listing
Access Red Blood Cell Folate Lysing Agent,Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG),AcT 5diff…
FDA device listing 1946850516 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | Access Red Blood Cell Folate Lysing Agent,Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG),AcT 5diff Fix,AcT 5diff Hgb Lyse,AcT 5diff WBC Lyse,AQUIOS Lysing Reagent Kit,COULTER DxH Cell Lyse,COULTER Rinsol Cleaning Agent,DxH 500 Series Lyse (PN B36846),DxH Cell Lyse 1L & 5L,DxH diff Pack,DxH ECO Cell Lyse (1L),DxH ECO Cell Lyse (5L),DxH Retic Pack,Fixative Solution (10X),IMMUNOPREP… |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Product codes | GGK |
| Device names | GGK - Products, Red-Cell Lysing Products |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8540 |
| Review panels | Hematology |
| Registered establishments | Beckman Coulter GmbH, Beckman Coulter, Inc., BECKMAN COULTER, INC., Beckman Coulter Ireland Inc, Immunotech SAS, a Beckman Coulter company |
| Establishment registrations | 1017835, 1061932, 2050010, 2122870, 8023018, 9680746, 3002721051, 3008629785 |
| FEI numbers | 1017835, 2050010, 2122870, 1000206808, 3000203293, 3002721051, 3002807272, 3008629785 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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