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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.
 
DeviceLIAISON XL MUREX HCV Ab
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantDiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
PMA NumberP190011
Supplement NumberS001
Date Received02/13/2020
Decision Date04/08/2020
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for System software update from software version 4.2.1.1 to software version 4.2.2.2 on the LIAISON® XL analyzer.
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