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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device des-gamma-carboxy-prothrombin (dcp), risk assessment, hepatocellular carcinoma
Regulation Description AFP-L3% immunological test system.
Definition The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.
Product CodeOAU
Regulation Number 866.6030
Device Class 2

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