21 CFR 862.1060
§ 862.1060 Delta-aminolevulinic acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1060, § 862.1060 Delta-aminolevulinic acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89045
- Permanent ID
ys:prov:89045@1- SHA-256
79428c981f5588cf23d45a2274fc817e221e96b806f4931891f7be7714b77258
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Full text
(a) Identification. A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).
(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.