21 CFR § 862.3830 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3830 Salicylate test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

(b) Classification. Class II.

← § 862.3800 Reagents for molecular diagnostic instrument test systems.§ 862.3840 Sirolimus test system. →