§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(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.