§ 862.3560 Lithium test system.
Current through Sep 8, 2026 · Read all of Part 862
(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.