LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers

FDA Premarket Approval P180039 S011

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-HBs assay, Control and Verifiers
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-05
Decision Date2022-06-23
PMAP180039
SupplementS011
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin Inc.
1951 Northwestern Avenue
stillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The Addition Of The Alternate Supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), To Produce Vial And Frame Plastics Components Of The Reagent Integral.

Supplemental Filings

Supplement NumberDateSupplement Type
P180039Original Filing
S013 2022-11-10 30-day Notice
S012
S011 2022-04-05 Real-time Process
S010 2022-04-05 30-day Notice
S009 2022-02-04 Real-time Process
S008 2021-11-23 30-day Notice
S007 2021-11-23 30-day Notice
S006 2021-11-23 30-day Notice
S005
S004 2021-05-27 Real-time Process
S003
S002 2020-07-16 30-day Notice
S001 2020-06-18 Real-time Process

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