21 CFR § 862.3450 - Gentamicin test system.

---
identifier: "/us/cfr/t21/s862.3450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3450 - Gentamicin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3450"
section_name: "Gentamicin 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"
---


# 862.3450 Gentamicin test system.

(a) *Identification.* A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

(b) *Classification.* Class II.