21 CFR 862.1190
§ 862.1190 Copper test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1190, § 862.1190 Copper test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89078
- Permanent ID
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Full text
(a) Identification. A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of copper are used in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a hereditary disease primarily of the liver and nervous system). Test results are also used in monitoring patients with Hodgkin's disease (a disease primarily of the lymph system).
(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 the limitations in § 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.