21 CFR § 862.3320 - Digoxin test system.

---
identifier: "/us/cfr/t21/s862.3320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3320 - Digoxin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3320"
section_name: "Digoxin 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"
---


# 862.3320 Digoxin test system.

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

(b) *Classification.* Class II.