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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 system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
De Novo Number DEN130032
510(K) Number K131706
Device Name XPERT MTB/RIF ASSAY
Requester
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089
Contact kerry j flom
Regulation Number866.3373
Classification Product Code
PEU  
Date Received06/11/2013
Decision Date 07/25/2013
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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