§ 862.1245. Dehydroepiandrosterone (free and sulfate) test system.
83 words·~1 min read·
/us/cfr/t21/s§ 862.1245·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]