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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 non-variola orthopoxvirus real-time pcr primer and probe set
De Novo Number DEN070001
Device Name NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Requester
centers for disease control and prevention
1600 clifton rd., ne
atlanta,  GA  30333
Contact hye-joo kim
Regulation Number866.3315
Classification Product Code
PBK  
Date Received01/16/2007
Decision Date 09/21/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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