§862.1285. Etiocholanolone test system.
21 C.F.R. § 862.1285
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]