21 CFR § 862.3035 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3035 Amikacin test system.

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

⚠ 2 pending changes to Part 862

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

(b) Classification. Class II.

← § 862.3030 Acetaminophen test system.§ 862.3040 Alcohol test system. →