Device |
test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment |
Definition |
In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months. Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology. |
Product Code | NSF |
Regulation Number |
866.6030
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Device Class |
2
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