21 CFR 862.3300

§ 862.3300 Digitoxin test system.

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

Cite this

Citation: 21 CFR 862.3300, § 862.3300 Digitoxin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89259
Permanent ID: ys:prov:89259@1
SHA-256: 4bfe5a180b3c471b7fb02b9f6bcbf661fcd319d7fb5592d0f82daa986b7c8496

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Full text

(a) Identification. A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin 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.