21 CFR § 862.3350 - Diphenylhydantoin test system.

---
identifier: "/us/cfr/t21/s862.3350"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3350 - Diphenylhydantoin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3350"
section_name: "Diphenylhydantoin test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.3350 Diphenylhydantoin test system.

(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.