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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment
Regulation Description AFP-L3% immunological test system.
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 CodeNSF
Regulation Number 866.6030
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II Apr-13-2021
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