FDA device listing
Alinity c Microalbumin Calibrators - LN 08P0401,Alinity c Microalbumin Controls - LN 08P0410,Alinity c Microalbumin…
FDA device listing 1836989648 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity c Microalbumin Calibrators - LN 08P0401,Alinity c Microalbumin Controls - LN 08P0410,Alinity c Microalbumin Reagent Kit - LN 08P0420,Microalbumin (Alinity c, LN 08P0424),Microalbumin (ARCHITECT; LN 02K9824),Microalbumin Calibrators (Alinity c, LN 08P0404),Microalbumin Calibrators (ARCHITECT; LN 02K9804),Microalbumin Calibrators - LN 02K9802 and 02K9803,Microalbumin Controls (Alinity c, LN… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K030320 |
| Product codes | JIQ, JIS, JJX |
| Device names | JIQ - Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), JIS - Calibrator, Primary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1645, 862.1660 |
| 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, 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