21 CFR 862.1590
§ 862.1590 Porphobilinogen test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1590, § 862.1590 Porphobilinogen test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89164
- Permanent ID
ys:prov:89164@1- SHA-256
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Full text
(a) Identification. A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine 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.