21 CFR § 862.3670 - Phenothiazine test system.

---
identifier: "/us/cfr/t21/s862.3670"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3670 - Phenothiazine test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3670"
section_name: "Phenothiazine 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"
---


# 862.3670 Phenothiazine test system.

(a) *Identification.* A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.

(b) *Classification.* Class II.