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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, epithelial ovarian tumor associated antigen (he4)
Regulation Description Tumor-associated antigen immunological test system.
Definition 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.
Product CodeOIU
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 1
Total Device Problems 1

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