21 CFR § 862.3035 - Amikacin test system.

---
identifier: "/us/cfr/t21/s862.3035"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3035 - Amikacin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3035"
section_name: "Amikacin 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"
---


# 862.3035 Amikacin test system.

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

(b) *Classification.* Class II.