FDA device listing
EliA APS Positive Control 250,EliA B2-Glycoprotein I IgG,EliA B2-Glycoprotein I IgM,EliA Cardiolipin IgG,EliA…
FDA device listing 1684629199 · PHADIA AB
Key facts
| Proprietary names | EliA APS Positive Control 250,EliA B2-Glycoprotein I IgG,EliA B2-Glycoprotein I IgM,EliA Cardiolipin IgG,EliA Cardiolipin IgM,EliA IgG/IgM/IgA Negative Control 250,EliA IgM Calibrator Strips,EliA IgM Calibrator Well,EliA IgM Conjugate 200,EliA IgM Conjugate 50,EliA IgM Curve Control Strips |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K091845 |
| Product codes | JJY, MID, MSV |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed), MID - System, Test, Anticardiolipin Immunological, MSV - System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1660, 866.5660 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | PHADIA AB, PHADIA US INC. |
| Establishment registrations | 9610566, 3004973408, 3039353646 |
| FEI numbers | 3002807876, 3004973408, 3039353646 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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