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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 vaginitis and bacterial vaginosis nucleic acid detection system
De Novo Number DEN160001
Device Name BD MAX Vaginal Panel, BD MAX Instrument
Requester
geneohm sciences canada, inc. (bd diagnostics)
2555 boul. de parc-technologique
quebec,  CA gip 4s5
Contact manon richard
Regulation Number866.3975
Classification Product Code
PQA  
Date Received01/11/2016
Decision Date 10/28/2016
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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