21 C.F.R. § 862.3450

Current through September 30, 2024
Section 862.3450 - Gentamicin test system
(a)Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
(b)Classification. Class II.

21 C.F.R. § 862.3450