21 CFR § 862.3520 - Kanamycin test system.

---
identifier: "/us/cfr/t21/s862.3520"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3520 - Kanamycin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3520"
section_name: "Kanamycin 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"
---


# 862.3520 Kanamycin test system.

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

(b) *Classification.* Class II.