21 C.F.R. § 862.1710 Total triiodothyronine test system.
Title 21 - Food and Drugs
(a) Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. (b) Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000]
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§ 862.1710 Total triiodothyronine test system.
