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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., serum) to determine metabolites of vitamin D, both of vitamin D2 (ergocalciferol) or D3 (cholecalciferol). These assays are not designed to differentiate between D2 and D3 metabolites because both produce dihydroxylated metabolites of similar if not equal biological activity. Determination of circulating vitamin D metabolites (e.g., 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D) is easier and likely reflects the vitamin D status better than the assays of vitamin D itself. A large number of bone and mineral metabolism disorders are associated with abnormal levels of vitamin D and/or its metabolites.
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