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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORAQUICK HCV RAPID ANTIBODY TEST
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantORASURE TECHNOLOGIES INC.
220 East First Street
Bethlehem, PA 18015
PMA NumberP080027
Supplement NumberS017
Date Received06/06/2014
Decision Date09/02/2014
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE EXPIRATION DATING FOR THE ORAQUICK® HCV VISUAL REFERENCE PANEL TO A FIVE MONTH EXPIRATION DATE FOR POUCHED AND UN-POUCHED DEVICES THAT ARE PROTECTED FROM LIGHT AND 15 DAYS FOR DEVICES THAT ARE NOT PROTECTED FROM LIGHT.
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