21 CFR 862.1390
§ 862.1390 5-Hydroxyindole acetic acid/serotonin test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1390, § 862.1390 5-Hydroxyindole acetic acid/serotonin test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89122
- Permanent ID
ys:prov:89122@1- SHA-256
30c29dd3f5b4d80454b47c277ff4ee3dafd9788a6550312bcbe2a7d1bde93478
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Full text
(a) Identification. A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.
(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.