21 CFR 862.3950

§ 862.3950 Vancomycin test system.

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

Cite this

Citation: 21 CFR 862.3950, § 862.3950 Vancomycin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89294
Permanent ID: ys:prov:89294@1
SHA-256: 42811c3db31ae945c5d62ef1582241f3d3a745588bec106858c2a0e91a63357c

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Full text

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