FDA device listing
ODC0026 CRP LATEX CALIBRATOR NORMANL (N) SET,ODC0027 CRP LATEX CALIBRATOR HIGHLY SENSITIVE (HS) SET,OSR6199 CRP LATEX
FDA device listing 1458323327 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | ODC0026 CRP LATEX CALIBRATOR NORMANL (N) SET,ODC0027 CRP LATEX CALIBRATOR HIGHLY SENSITIVE (HS) SET,OSR6199 CRP LATEX |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K051564 |
| Product codes | JIT, NQD |
| Device names | JIT - Calibrator, Secondary, NQD - Cardiac C-Reactive Protein, Antigen, Antiserum, And Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 866.5270 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | Beckman Coulter Ireland Inc |
| Establishment registrations | 9680746 |
| FEI numbers | 1000206808 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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