FDA device listing
Alinity i T-Uptake Reagent Kit (LN 08P1220),ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825)
FDA device listing 1779903801 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i T-Uptake Reagent Kit (LN 08P1220),ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | KHQ |
| Device names | KHQ - Radioassay, Triiodothyronine Uptake |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1715 |
| 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
- 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