21 C.F.R. § 862.1245

Current through October 31, 2024
Section 862.1245 - Dehydroepiandrosterone (free and sulfate) test system
(a)Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
(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. §862.1245

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