Code of Federal Regulations · Section
§ 862.3550 — Lead Test System
21 C.F.R. § 862.3550
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351