21 CFR § 862.3320 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3320 Digoxin test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

(b) Classification. Class II.

← § 862.3300 Digitoxin test system.§ 862.3350 Diphenylhydantoin test system. →