LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual

FDA Premarket Approval P190017 S005

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 HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS005 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
PMAP190017
SupplementS005
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 NumberP190017 Supplement NumberS005 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
P190017Original Filing
S005 2022-04-05 30-day Notice
S004 2022-02-04 Real-time Process
S003 2021-11-19 Real-time Process
S002 2021-05-27 Real-time Process
S001

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