21 CFR § 862.3300 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3300 Digitoxin test system.

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

⚠ 2 pending changes to Part 862

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

(b) Classification. Class II.

← § 862.3280 Clinical toxicology control material.§ 862.3320 Digoxin test system. →