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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
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameassay,enzyme linked immunosorbent,hepatitis c virus
Applicant
ORASURE TECHNOLOGIES INC.
220 east first street
bethlehem, PA 18015
PMA NumberP080027
Supplement NumberS005
Date Received03/16/2011
Decision Date07/27/2011
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE OPTION TO AUTOMATE THE MANUFACTURING PROCESS FOR ASSEMBLY OF THE ORAQUICK® HCV RAPID ANTIBODY TEST.
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