Electronic Code of Federal Regulations
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e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1685 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1685 Thyroxine-binding globulin test system.
(a) Identification. A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
(b) Classification. Class II (special controls). The 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 84 FR 71797, Dec. 30, 2019]