21 CFR 862.3450

§ 862.3450 Gentamicin test system.

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

Cite this

Citation: 21 CFR 862.3450, § 862.3450 Gentamicin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89265
Permanent ID: ys:prov:89265@1
SHA-256: 1f043ccc863c9a5917fcaa9742371cde3464a6dd03b87f51327676dd5bf6e9e7

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Full text

(a) Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin 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.