21 CFR § 862.3450 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3450 Gentamicin test system.

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

⚠ 2 pending changes to Part 862

(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.

← § 862.3380 Ethosuximide test system.§ 862.3460 Plazomicin test system. →