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.
Leading manufacturers include Wako Chemicals USA, Inc..
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
Cleared
Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
Wako Chemicals USA, Inc.
Immunology
370d
Not Cleared
May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Wako Chemicals USA, Inc.
Immunology
42d