21 CFR 862.3350
§ 862.3350 Diphenylhydantoin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.3350, § 862.3350 Diphenylhydantoin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89261
- Permanent ID
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Full text
(a) Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin 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.