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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 culture-based short-term incubation antimicrobial resistance assay
De Novo Number DEN190016
Device Name cobas vivoDx MRSA
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton,  CA  94588 -2722
Contact nobuko nakajima
Regulation Number866.1655
Classification Product Code
Date Received03/19/2019
Decision Date 12/05/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct