21 CFR 862.3560

§ 862.3560 Lithium test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.3560, § 862.3560 Lithium test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89270
Permanent ID: ys:prov:89270@1
SHA-256: d171beb95af5bb79d3362e993c3e075d94953bfd7a1467c8408e16caae7734fe

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.