21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1665

Sodium test system.

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

21 C.F.R. § 862.1665 — Sodium test system.

§ 862.1665 Sodium test system. (a) Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. (b) Classification. Class II.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 862.1665
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The regulatory text of 21 C.F.R. § 862.1665 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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