FDA device listing
ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC
FDA device listing 1247474636 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K254059 |
| Product codes | SEI |
| Device names | SEI - Qualitative And Quantitative Hepatitis B Virus Antibody Assays |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3173 |
| Review panels | Microbiology |
| Registered establishments | Beckman Coulter Ireland Inc, Immunotech SAS, a Beckman Coulter company |
| Establishment registrations | 8023018, 9680746 |
| FEI numbers | 1000206808, 3002807272 |
| Establishment operations | Contract Manufacturer, 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