← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.6030
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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