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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 zika virus serological reagents
De Novo Number DEN180069
Device Name ZIKV Detect 2.0 IgM Capture ELISA
InBios International, Inc.
307 westlake ave n, suite 300
seattle,  WA  98109
Contact estela raychaudhuri
Regulation Number866.3935
Classification Product Code
Date Received12/26/2018
Decision Date 05/23/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct