21 CFR § 862.3550 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3550 Lead test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

(b) Classification. Class II.

← § 862.3520 Kanamycin test system.§ 862.3555 Lidocaine test system. →