21 CFR § 862.3560 - Lithium test system.

---
identifier: "/us/cfr/t21/s862.3560"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3560 - Lithium test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3560"
section_name: "Lithium 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"
---


# 862.3560 Lithium test system.

(a) *Identification.* A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

(b) *Classification.* Class II.