FDA device listing
Alinity c Microalbumin Calibrators,Alinity c Microalbumin Controls,Alinity c Microalbumin Reagent Kit,Autokit Micro…
FDA device listing 2040105417 · FUJIFILM CORPORATION
Key facts
| Proprietary names | Alinity c Microalbumin Calibrators,Alinity c Microalbumin Controls,Alinity c Microalbumin Reagent Kit,Autokit Micro Albumin,Autokit Micro Albumin Calibrator Set,Autokit Micro Albumin Control Set,Microalbumin,Microalbumin Calibrators,Microalbumin Controls |
|---|---|
| Owner/operator | FUJIFILM CORPORATION |
| Owner/operator number | 8031568 |
| 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 | FUJIFILM Healthcare Americas Corporation |
| Establishment registrations | 3005625991 |
| FEI numbers | 3005625991 |
| Establishment operations | 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