FDA device listing
Alinity i B12 Reagent Kit (LN 07P6721, 07P6731),ARCHITECT B12 Calibrators (LN 7K61-02),ARCHITECT B12 Controls (LN…
FDA device listing 1010283374 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i B12 Reagent Kit (LN 07P6721, 07P6731),ARCHITECT B12 Calibrators (LN 7K61-02),ARCHITECT B12 Controls (LN 7K61-12),ARCHITECT B12 Reagent Kit (LN 7K61-27, 7K61-37) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K121314 |
| Product codes | CDD, JIT, JJX |
| Device names | CDD - Radioassay, Vitamin B12, JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 862.1810 |
| 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
- 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