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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 gastrointestinal pathogen panel multiplex nucleic acid-based assay system
De Novo Number DEN130003
510(K) Number K121454
Device Name XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
Requester
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
suite 900
toronto,  CA m5g 1y8
Contact lubna syed
Regulation Number866.3990
Classification Product Code
PCH  
Date Received01/11/2013
Decision Date 01/14/2013
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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