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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
Regulation Number866.3169
ApplicantOraSure Technologies, Inc.
220 E. First St.
Bethlehem, PA 18015
PMA NumberP080027
Supplement NumberS005
Date Received03/16/2011
Decision Date07/27/2011
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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