21 C.F.R. § 862.3555
Lidocaine test system.
Cite as 21 C.F.R. § 862.3555 (2026)
(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.