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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Gene region specific amplification test system. Should not include products not intended for export only or for products intended for re-importation into the USA
Technical Method Uses polymerase chain reaction (PCR) and amplicon fragment sizing on a DNA genetic analyzer or capillary electrophoresis platform to determine the number of triplet repeats.
Target Area Peripheral human whole blood or human tissue.
Review Panel Immunology
Product CodeOYV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible