21 CFR § 862.1205 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1200 Corticosterone test system.§ 862.1210 Creatine test system. →