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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 lower respiratory microbial nucleic acid detection system
De Novo Number DEN170047
Device Name Curetis Unyvero LRT Application
Curetis GmbH
max-eyth strabe 42
holzgerlingen,  DE 71088
Contact gail e. radcliffe
Regulation Number866.3985
Classification Product Code
Date Received09/11/2017
Decision Date 04/03/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct