FDA device listing
Access 25(OH) Vitamin D Total (A98856 MN and IE MFG),Access 25(OH) Vitamin D Total (C28646 MN MFG)
FDA device listing 1007533698 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | Access 25(OH) Vitamin D Total (A98856 MN and IE MFG),Access 25(OH) Vitamin D Total (C28646 MN MFG) |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K223503 |
| Product codes | MRG |
| Device names | MRG - System, Test, Vitamin D |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1825 |
| Review panels | Clinical Chemistry |
| Registered establishments | BECKMAN COULTER, INC., Beckman Coulter Ireland Inc, Immunotech SAS, a Beckman Coulter company |
| Establishment registrations | 2122870, 8023018, 9680746 |
| FEI numbers | 2122870, 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