21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1045

Aldosterone test system.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 862.1045 — Aldosterone test system.

§ 862.1045 Aldosterone test system. (a) Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance. (b) Classification. Class II.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 862.1045
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The regulatory text of 21 C.F.R. § 862.1045 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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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 862.1045