FDA device listing
EliA Cardiolipin IgA Immunoassay
FDA device listing 1066749920 · PHADIA AB
Key facts
| Proprietary names | EliA Cardiolipin IgA Immunoassay |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K131821 |
| Product codes | JJY, MID |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed), MID - System, Test, Anticardiolipin Immunological |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1660, 866.5660 |
| Review panels | Clinical Chemistry, 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
- None 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