part_subject: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
subpart_code: "B"
subpart_subject: "Clinical Chemistry Test Systems"
section_number: "862.1690"
section_subject: "Thyroid stimulating hormone test system."
cfr_reference: "21 CFR 862.1690"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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.