21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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.
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