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  • Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three copies of chromosome 21 in a patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy 21). Trisomy 21 causes Down syndrome. Molecular tests for Down syndrome are typically used for prenatal diagnosis in pregnant women.
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