FDA device listing
uTASWako AFP-L3 Calibrator Set,uTASWako AFP-L3 Control L and H,uTASWako AFP-L3 Immunological Test System,uTASWako AFP-L3…
FDA device listing 1090024306 · FUJIFILM Wako Pure Chemical Corporation
Key facts
| Proprietary names | uTASWako AFP-L3 Calibrator Set,uTASWako AFP-L3 Control L and H,uTASWako AFP-L3 Immunological Test System,uTASWako AFP-L3 Sample Dilution Buffer,uTASWako Chip Cassette,uTASWako DCP Calibrator Set,uTASWako DCP Control L and H,uTASWako DCP Immunological Test System,uTASWako i30 Immunoanalyzer System,uTASWako Wash Solution |
|---|---|
| Owner/operator | FUJIFILM Wako Pure Chemical Corporation |
| Owner/operator number | 8030234 |
| Premarket submissions | K100464 |
| Product codes | JIT, JJX, NSF, OAU, OUE |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), NSF - Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment, OAU - Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma, OUE - Micro Total Analysis Instrument System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 862.2570, 866.6030 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | FUJIFILM Healthcare Manufacturing Corporation MIE Office, FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) |
| Establishment registrations | 3003419906, 3003522182 |
| FEI numbers | 3003419906, 3003522182 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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