21 CFR § 862.3900 - Tobramycin test system.

---
identifier: "/us/cfr/t21/s862.3900"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3900 - Tobramycin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3900"
section_name: "Tobramycin 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"
---


# 862.3900 Tobramycin test system.

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

(b) *Classification.* Class II.