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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 variola virus nucleic acid-based detection assay
De Novo Number DEN160016
Device Name Variola virus Real-Time PCR Assay
Requester
centers for disease control and prevention (cdc)
1600 clifton rd. ne, ms-c18
atlanta,  GA  30329
Contact yon yu
Regulation Number866.3316
Classification Product Code
PRA  
Date Received04/14/2016
Decision Date 02/06/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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