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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name inherited nucleotide repeat disorder dna test
De Novo Number DEN190023
Device Name AmplideX Fragile X Dx & Carrier Screen Kit
Asuragen, Inc.
2150 woodward, suite 100
austin,  TX  78744
Contact bernard andruss
Regulation Number866.5970
Classification Product Code
Date Received04/18/2019
Decision Date 02/21/2020
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Molecular Genetics
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct