Pure Global

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma 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.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OAU

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Class 2

21 CFR 866.6030

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Immunology

Device Characteristics

No

No

No

Eligible

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.