21 CFR § 862.3300 - Digitoxin test system.

---
identifier: "/us/cfr/t21/s862.3300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3300 - Digitoxin test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3300"
section_name: "Digitoxin 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"
---


# 862.3300 Digitoxin test system.

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

(b) *Classification.* Class II.