21 C.F.R. § 862.3035

Amikacin test system.

Last amended: 2016Year: 2026Length: 50 wordsSubsections: 1Official source

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.
21 C.F.R. § 862.3035: Amikacin test system. | Justis AI