FDA device listing
Alinity i Intact PTH Reagent Kit (LN 08P3121),ARCHITECT iPTH Calibrators (LN 8K25-04),ARCHITECT iPTH Controls (LN…
FDA device listing 1845986861 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i Intact PTH Reagent Kit (LN 08P3121),ARCHITECT iPTH Calibrators (LN 8K25-04),ARCHITECT iPTH Controls (LN 8K25-13),ARCHITECT iPTH Reagent Kit (LN 8K25-29) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K063232 |
| Product codes | CEW, JIT, JJX |
| Device names | CEW - Radioimmunoassay, Parathyroid Hormone, JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1545, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT GmbH, ABBOTT LABORATORIES |
| Establishment registrations | 3002809144, 3005333358 |
| FEI numbers | 3002809144, 3005333358 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| 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