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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 device to detect antigens of biothreat microbial agents in human clinical specimens
De Novo Number DEN190025
Device Name OraQuick Ebola Rapid Antigen Test
OraSure Technologies, Inc.
220 east first street
bethlehem,  PA  18015
Contact tiffany miller
Regulation Number866.4002
Classification Product Code
Date Received05/13/2019
Decision Date 10/10/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct