FDA Product Code NSF: Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment
In Vitro Diagnostic Test Intended As A Risk Assessment Test For The Development Of Hepatocellular Carcinoma (hcc) In Patients With Chronic Liver Diseases (cld). Elevated Afpl3% Values (= 10%) Have Been Shown To Be Associated With A Nine-fold Increase In The Risk Of Developing Hcc In The Next 6-12 Months. Patients With Elevated Serum Afpl3% Should Be More Intensely Evaluated For Evidence Of Hcc According To The Existing Hcc Practice Guidelines In Oncology.
2
Total
1
Cleared
206d
Avg days
2005
Since
FDA 510(k) Cleared Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment Devices (Product Code NSF)
2 devices
No devices found for this product code.