21 CFR 862.1790
§ 862.1790 Uroporphyrin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1790, § 862.1790 Uroporphyrin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89201
- Permanent ID
ys:prov:89201@1- SHA-256
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Full text
(a) Identification. A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.
(b) Classification. Class I (general controls). The device is exempt from the 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.