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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 lateral flow immunochromatography assay for host infection biomarkers
De Novo Number DEN180032
Device Name Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Requester
cd diagnostics inc.
650 naamans road, suite 100
claymount,  DE  19703
Contact sujith kallur
Regulation Number866.3230
Classification Product Code
QGN  
Date Received06/29/2018
Decision Date 05/23/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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