21 CFR § 862.3680 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3680 Primidone test system.

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

⚠ 2 pending changes to Part 862

(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.

(b) Classification. Class II.

← § 862.3670 Phenothiazine test system.§ 862.3700 Propoxyphene test system. →