21 CFR § 862.3900 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3900 Tobramycin test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.3880 Theophylline test system.§ 862.3910 Tricyclic antidepressant drugs test system. →