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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
Applicant
DiaSorin Inc.
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP190011
Supplement NumberS002
Date Received06/18/2020
Decision Date08/06/2020
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 software version change to the LIAISON XL analyzer software.
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