FDA device listing
EliA ANA 3 Positive Control 250,EliA ANA 3 Positive Control 2500/5000,EliA ANA Positive Control 2500/5000,EliA ANCA/GBM…
FDA device listing 1590274360 · PHADIA AB
Key facts
| Proprietary names | EliA ANA 3 Positive Control 250,EliA ANA 3 Positive Control 2500/5000,EliA ANA Positive Control 2500/5000,EliA ANCA/GBM Positive Control 2500/5000,EliA APS Positive Control 2500/5000,EliA Celiac Positive Control 2500/5000,EliA dsDNA Positive Control 250,EliA dsDNA Positive Control 2500/5000,EliA M2 Positive Control 2500/5000,EliA RF Positive Control 2500/5000 |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Product codes | JJY |
| Device names | JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1660 |
| Review panels | Clinical Chemistry |
| 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
- None listed 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