21 CFR § 862.1690 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1690 Thyroid stimulating hormone test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

(b) Classification. Class II.

← § 862.1685 Thyroxine-binding globulin test system.§ 862.1695 Free thyroxine test system. →