21 CFR § 862.3520 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3520 Kanamycin test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.

(b) Classification. Class II.

← § 862.3460 Plazomicin test system.§ 862.3550 Lead test system. →