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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 simple point-of-care nucleic acid-based hepatitis c virus ribonucleic acid test
De Novo Number DEN240016
Device Name Xpert HCV; GeneXpert Xpress System
Requester
cepheid
904 caribbean dr.
sunnyvale,  CA  94089
Contact suzette chance
Regulation Number866.3171
Classification Product Code
SBP  
Date Received04/16/2024
Decision Date 06/27/2024
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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