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52 FR 16122, May 1, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 862.1545
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
(b) Classification. Class II.