Regulation Text
(a) Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
(b) Classification. Class II.
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.