21 CFR § 862.3660 - Phenobarbital test system.

---
identifier: "/us/cfr/t21/s862.3660"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3660 - Phenobarbital test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3660"
section_name: "Phenobarbital 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"
---


# 862.3660 Phenobarbital test system.

(a) *Identification.* A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

(b) *Classification.* Class II.