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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 fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp.
De Novo Number DEN160025
Device Name ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
797 san antonio road
palo alto,  CA  94303
Contact jyotsna shah
Regulation Number866.3367
Classification Product Code
Date Received06/27/2016
Decision Date 08/18/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct