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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device trinucleotide repeat disorder dna test
Definition The trinucleotide repeat disorder dna test is an in vitro diagnostic device intended to amplify and detect the presence of specific triplet nucleotide repeats to aid in the diagnosis of genetic inherited disorders associated with mental retardation or intellectual disabilities, early reproductive failure, or progressive neuro- or muscular-degenerative disorders. Identification and detection of specific full length gene fragment size and/or specific triplet repeats by polymerase chain reaction (pcr) of genomic dna purified from whole blood followed by fragment sizing on a dna genetic analyzer, capillary electrophoresis, or array-based platform to identify the number of triplet repeats.
Product CodeOYV
Device Class Not Classified