Title 21

SECTION 862.1695

862.1695 Free thyroxine test system.

§ 862.1695 Free thyroxine test system.

(a) Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

(b) Classification. Class II.