OAU · Class II · 21 CFR 866.6030

FDA Product Code 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.

1
Total
1
Cleared
170d
Avg days
2007
Since

FDA 510(k) Cleared Des-gamma-carboxy-prothrombin (dcp), Risk Assessment, Hepatocellular Carcinoma Devices (Product Code OAU)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OAU - Regulatory Context