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52 FR 16122, May 1, 1987, unless otherwise noted.
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and p lasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.
(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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]