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21 CFR 862.3320

§ 862.3320 Digoxin test system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 862.3320, § 862.3320 Digoxin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89260
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(a) Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. (b) Classification. Class II.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.