FDA device listing
Alinity i Refurbished Processing Module (LN 03R65-84),Alinity i System,Alinity i System Accessories,Alinity i Total…
FDA device listing 2037553514 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity i Refurbished Processing Module (LN 03R65-84),Alinity i System,Alinity i System Accessories,Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K170317 |
| Product codes | DHA, JJE |
| Device names | DHA - System, Test, Human Chorionic Gonadotropin, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1155, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT GmbH, ABBOTT IRELAND, ABBOTT IRELAND DIAGNOSTICS DIVISION, ABBOTT LABORATORIES, Abbott Laboratories de Mexico |
| Establishment registrations | 1415939, 3002809144, 3005094123, 3005333358, 3008344661, 3016244760, 3016438761 |
| FEI numbers | 1415939, 3002809144, 3005094123, 3005333358, 3008344661, 3016244760, 3016438761 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| 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