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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 assay, enterovirus nucleic acid
De Novo Number DEN070004
510(K) Number K061062
Device Name XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065
Requester
cepheid
904 caribbean drive
sunnyvale,  CA  94089 -1189
Contact russel k enns, ph.d.
Regulation Number866.3225
Classification Product Code
OAI  
Date Received03/12/2007
Decision Date 03/16/2007
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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