U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
(a) Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
(b) Classification. Class I.