21 CFR § 862.3555 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3555 Lidocaine test system.

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

⚠ 2 pending changes to Part 862

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

(b) Classification. Class II.

← § 862.3550 Lead test system.§ 862.3560 Lithium test system. →