StacksVerified U.S. regulatory reference

21 CFR §862.3680

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.
  2. (b)Classification. Class II.