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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 NumberS039
Date Received03/25/2021
Decision Date04/20/2021
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing process improvements.
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