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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, LIAISON XL MUREX Control HCV Ab
Generic Nameassay, enzyme linked immunosorbent, hepatitis c virus
Applicant
DiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP190011
Supplement NumberS004
Date Received05/27/2021
Decision Date08/10/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software version change for the LIAISON XL Analyzer from the approved LIAISON XL version 4.2.2.3 SP1 to software version 4.2.2.4.
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