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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
Requester
roche molecular systems, inc.
4300 hacienda dr.
pleasanton,  CA  94588
Contact nobuko nakajima
Regulation Number866.1655
Classification Product Code
QIV  
Date Received03/19/2019
Decision Date 12/05/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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