Device typeTotal estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total estrogen (oestrogen) hormones [estradiol, estriol, and estrone] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of sex steroid metabolism-related conditions (e.g., premature or delayed puberty), or assessment of fracture risk and monitoring of hormone replacement therapy in postmenopausal women.
FDA categoryRadioimmunoassay, Total Estrogens, Nonpregnancy
Device IDB261CANE6304PK0
Catalog numberCAN-E-630-4PK
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information