LIAISON® XL MUREX HBc lgM assay and Control

FDA Premarket Approval P180045 S007

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.

Pre-market Approval Supplement Details

DeviceLIAISON® XL MUREX HBc lgM assay and Control
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-02-04
Decision Date2022-05-05
PMAP180045
SupplementS007
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin Inc.
1951 Northwestern Avenue
stillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
To Allow The LIAISON XL Analyzer To Be Connected To The Beckman DxA 5000, An FDA-cleared Third Party Laboratory Automation System (LAS).

Supplemental Filings

Supplement NumberDateSupplement Type
P180045Original Filing
S008 2022-04-05 30-day Notice
S007 2022-02-04 Real-time Process
S006 2021-11-23 30-day Notice
S005 2021-11-23 30-day Notice
S004 2021-11-23 30-day Notice
S003
S002 2021-05-27 Real-time Process
S001

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