ZIKV Detect 2.0 IgM Capture ELISA

Zika Virus Serological Reagents

InBios International, Inc.

The following data is part of a De Novo classification by Inbios International, Inc. with the FDA for Zikv Detect 2.0 Igm Capture Elisa.

Pre-market Notification Details

DeNovo IDDEN180069
Device Name:ZIKV Detect 2.0 IgM Capture ELISA
ClassificationZika Virus Serological Reagents
Applicant InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle,  WA  98109
ContactEstela Raychaudhuri
Product CodeQFO  
CFR Regulation Number866.3935 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2018-12-26
Decision Date2019-05-23
Reclassification Order:Reclassification Order

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