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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1190


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1190   Copper test system.

(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.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]

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