21 CFR § 862.1495 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1495 Magnesium test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1493 Breast milk macronutrients test system.§ 862.1500 Malic dehydrogenase test system. →