21 C.F.R. § 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
