21 CFR 862.3550 — Lead, Delta Amino Levulinic Acid

Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3550

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
DIJLead, Delta Amino Levulinic Acid22
DMKLead, Protoporphyrin, Fluorometric20
DNXLead, Protoporphyrin Zinc Method, Fluorometric20
DOFLead, Atomic Absorption26
DOXFluorometer, Lead (Dedicated Instruments)24
Innolitics

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