21 C.F.R. § 862.3035
Amikacin test system.
Cite as 21 C.F.R. § 862.3035 (2026)
(a) Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy. (b) Classification. Class II.