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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 Number
866.3373
Classification Product Code
PEU
Date Received
06/11/2013
Decision Date
07/25/2013
Decision
granted (DENG)
Classification Advisory Committee
Microbiology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
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