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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
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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