Chromatographic Separation/Zimmerman, 17-Ketosteroids

The Chromatographic Separation/Zimmerman 17-Ketosteroids Test is a clinical chemistry device that employs chromatographic separation prior to the Zimmerman colorimetric reaction to achieve greater specificity in the quantification of 17-ketosteroid levels in urine, used to evaluate adrenal and gonadal androgen production. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDE, regulated under 21 CFR 862.1430, within the Clinical Chemistry medical specialty. No special flags apply to this device.