Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma
Immunology · 21 CFR 866.6030
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.
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Most-reported manufacturers
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Recalls
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Registered firms
4 firms currently registered for this product code
Fujifilm Healthcare Americas Corporation
Edison, NJ, US
Fujifilm Wako Pure Chemical Corporation Diagnostics Design Office (amagasaki)
Amagasaki-shi Hyogo, JP
Fujifilm Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
MINAMIASHIGARA-SHI Kanagawa, JP
Fujifilm Healthcare Manufacturing Corporation Mie Office
Komono-cho, Mie-gun, JP
510(k) clearances
1 clearances for this product code