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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 nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
De Novo Number DEN060008
510(K) Number K060159
Device Name INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
Requester
centers for disease control and prevention
1600 clifton rd. ne (ms c-12)
atlanta,  GA  30333
Contact hye-joo kim
Regulation Number866.3332
Classification Product Code
NXD  
Date Received01/27/2006
Decision Date 02/03/2006
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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