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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 bcr/abl1 monitoring test
De Novo Number DEN160003
Device Name Quantidex qPCR BCR-ABL IS Kit
2150 woodward, suite 100
austin,  TX  78744
Contact fayyaz memon
Regulation Number866.6060
Classification Product Code
Date Received01/19/2016
Decision Date 07/22/2016
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Molecular Genetics
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct