FDA device listing
Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831),ARCHITECt STAT CK-MB Calibrators (LN 2K42-01),ARCHITECT STAT…
FDA device listing 1124779476 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831),ARCHITECt STAT CK-MB Calibrators (LN 2K42-01),ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K041596 |
| Product codes | JHX, JIS |
| Device names | JHX - Fluorometric Method, Cpk Or Isoenzymes, JIS - Calibrator, Primary |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1215 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT GmbH, ABBOTT IRELAND, ABBOTT LABORATORIES |
| Establishment registrations | 3002809144, 3005333358, 3008344661 |
| FEI numbers | 3002809144, 3005333358, 3008344661 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Repackager/Relabeler |
| 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