21 CFR § 862.3950 - Vancomycin test system.

---
identifier: "/us/cfr/t21/s862.3950"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3950 - Vancomycin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3950"
section_name: "Vancomycin 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"
---


# 862.3950 Vancomycin test system.

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

(b) *Classification.* Class II.