FDA device listing
ABX PENTRA CRP CAL,ABX PENTRA CRP CP,ABX PENTRA IMMUNO I CONTROL L/H,ABX PENTRA LOW CRP CONTROL
FDA device listing 1341219266 · HORIBA ABX SAS
Key facts
| Proprietary names | ABX PENTRA CRP CAL,ABX PENTRA CRP CP,ABX PENTRA IMMUNO I CONTROL L/H,ABX PENTRA LOW CRP CONTROL |
|---|---|
| Owner/operator | HORIBA ABX SAS |
| Owner/operator number | 9036328 |
| Premarket submissions | K061138 |
| Product codes | DCK, JIS |
| Device names | DCK - C-Reactive Protein, Antigen, Antiserum, And Control, JIS - Calibrator, Primary |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 866.5270 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | HORIBA ABX SAS |
| Establishment registrations | 3000148879 |
| FEI numbers | 3000148879 |
| Establishment operations | Specification Developer |
| 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