LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe

FDA Premarket Approval P180049 S008

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 Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-05
Decision Date2022-05-06
PMAP180049
SupplementS008
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin Inc.
1951 Northwestern Avenue
stillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Introduce An Additional Supplier For An Assay Accessory

Supplemental Filings

Supplement NumberDateSupplement Type
P180049Original Filing
S008 2022-04-05 30-day Notice
S007 2022-02-04 Real-time Process
S006 2021-11-23 30-day Notice
S005
S004 2021-11-23 30-day Notice
S003
S002 2021-05-27 Real-time Process
S001

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