FDA device listing
ABX Pentra Micro ALB 2 Cal (Ref.1300032565),ABX Pentra Micro ALBUMIN 2 CP (Ref.1300032563)
FDA device listing 1706325932 · HORIBA ABX SAS
Key facts
| Proprietary names | ABX Pentra Micro ALB 2 Cal (Ref.1300032565),ABX Pentra Micro ALBUMIN 2 CP (Ref.1300032563) |
|---|---|
| Owner/operator | HORIBA ABX SAS |
| Owner/operator number | 9036328 |
| Product codes | DCF |
| Device names | DCF - Albumin, Antigen, Antiserum, Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5040 |
| Review panels | 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
- 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