FDA device listing
EliA Jo-1,EliA RNP70
FDA device listing 1535846831 · PHADIA AB
Key facts
| Proprietary names | EliA Jo-1,EliA RNP70 |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K083117 |
| Product codes | LJM, LKO |
| Device names | LJM - Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, LKO - Anti-Rnp Antibody, Antigen And Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5100 |
| Review panels | Immunology |
| Registered establishments | PHADIA AB, PHADIA GMBH, PHADIA US INC. |
| Establishment registrations | 9610566, 9680745, 3004973408, 3039353646 |
| FEI numbers | 3002807876, 3004973408, 3005774014, 3039353646 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract 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