OIU · Class II · 21 CFR 866.6010

FDA Product Code OIU: Test, Epithelial Ovarian Tumor Associated Antigen (he4)

An Enzyme Immunometric Assay For The Quantitative Determination Of He4 In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Recurrence Or Progressive Disease In Patients With Epithelial Ovarian Cancer. Serial Testing For Patient He4 Assay Values Should Be Used In Conjunction With Other Clinical Methods Used For Monitoring Ovarian Cancer. It Is Not Intended To Estimate Or Assess The Risk Of Disease Outcomes Of Patients.

5
Total
5
Cleared
218d
Avg days
2008
Since

FDA 510(k) Cleared Test, Epithelial Ovarian Tumor Associated Antigen (he4) Devices (Product Code OIU)

5 devices
1–5 of 5
No devices found for this product code.

About Product Code OIU - Regulatory Context