21 CFR § 862.1690 - Thyroid stimulating hormone test system.

---
identifier: "/us/cfr/t21/s862.1690"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1690 - Thyroid stimulating hormone test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1690"
section_name: "Thyroid stimulating hormone test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1690 Thyroid stimulating hormone test system.

(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.

(b) *Classification.* Class II.