Device typeHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.
FDA categoryTest, Epithelial Ovarian Tumor Associated Antigen (He4)
Device ID17350066140326
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
SizeSize Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests