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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 gram-positive bacteria and their resistance markers
De Novo Number DEN120014
510(K) Number K113450
Device Name VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Requester
nanosphere, inc.
4088 commercial ave.
northbrook,  IL  60062
Contact mark del vecchio
Regulation Number866.3365
Classification Product Code
PAM  
Date Received06/15/2012
Decision Date 06/26/2012
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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