FDA device listing
Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030),Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430)
FDA device listing 1534300189 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030),Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K203248 |
| Product codes | CIX |
| Device names | CIX - Bromcresol Green Dye-Binding, Albumin |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1035 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT GmbH, ABBOTT IRELAND DIAGNOSTICS DIVISION, ABBOTT LABORATORIES |
| Establishment registrations | 3002809144, 3005094123, 3005333358 |
| FEI numbers | 3002809144, 3005094123, 3005333358 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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