StacksVerified U.S. regulatory reference

21 CFR §862.3320

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II.