Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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US Regulatory Classifications
Device Characteristics
No
No
No
Eligible
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.
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