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  • Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three chromosomes in a patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy). Congenital trisomies are typically characterized by physical and developmental disorders. The most common congenital trisomies occur in chromosome 21 (i.e., Down syndrome), chromosome 18 (i.e., Edwards\' syndrome), and chromosome 13 (i.e., Patau\'s syndrome); but trisomies may occur in other chromosomes (e.g., 8, 11, 22).
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