21 CFR § 862.3555 - Lidocaine test system.

---
identifier: "/us/cfr/t21/s862.3555"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3555 - Lidocaine test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3555"
section_name: "Lidocaine 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"
---


# 862.3555 Lidocaine test system.

(a) *Identification.* A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

(b) *Classification.* Class II.