21 CFR 862.1165
§ 862.1165 Catecholamines (total) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1165, § 862.1165 Catecholamines (total) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89071
- Permanent ID
ys:prov:89071@1- SHA-256
6e18dfd04236a543e1ef293d64150c6feba52fba567d92d1980acfb1929bfde8
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Full text
(a) Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).
(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.