21 C.F.R. § 862.1205

Cortisol (hydrocortisone and hydroxycorticosterone) test system.

Last amended: 2016Year: 2026Length: 47 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1205 (2026)

(a) Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland. (b) Classification. Class II.
21 C.F.R. § 862.1205: Cortisol (hydrocortisone and hydroxycorticosterone) test system. | Justis AI