21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1685

Thyroxine-binding globulin test system.

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Regulatory Text

21 C.F.R. § 862.1685 — Thyroxine-binding globulin test system.

§ 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]

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21 C.F.R. § 862.1685
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The regulatory text of 21 C.F.R. § 862.1685 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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