OraQuick Ebola Rapid Antigen Test

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

OraSure Technologies, Inc.

The following data is part of a De Novo classification by Orasure Technologies, Inc. with the FDA for Oraquick Ebola Rapid Antigen Test.

Pre-market Notification Details

DeNovo IDDEN190025
Device Name:OraQuick Ebola Rapid Antigen Test
ClassificationDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Applicant OraSure Technologies, Inc. 220 East First Street Bethlehem,  PA  18015
ContactTiffany Miller
Product CodeQID  
CFR Regulation Number866.4002 [🔎]
DecisionGranted (DENG)
510(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 Received2019-05-13
Decision Date2019-10-10
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00608337001433 DEN190025 000

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