Code of Federal Regulations · Section
§ 862.1205 — Cortisol (hydrocortisone And Hydroxycorticosterone) Test System
21 C.F.R. § 862.1205
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351