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Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
FDA product code NSF · Class 2 · Immunology
8
Registered devices
2
Adverse events
1
Recalls
2
510(k) clearances
Devices with this code
uTASWako Chip Cassette — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako AFP-L3 Sample Dilution Buffer — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako AFP-L3 Sample Dilution Buffer — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako Wash Solution — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako AFP-L3 — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako Wash Solution — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako Chip Cassette — FUJIFILM WAKO PURE CHEMICAL CORPORATIONuTASWako AFP-L3 — FUJIFILM WAKO PURE CHEMICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-18 | Fujifilm Medical Systems U.S.A., Inc. | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result |
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