21 C.F.R. § 862.1285

Current through October 31, 2024
Section 862.1285 - Etiocholanolone test system
(a)Identification. An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and treatment of disorders of the testes and ovaries.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.1285

52 FR 16122, May 1, 1987, as amended at 65 FR 2306 , Jan. 14, 2000