LIAISON® XL MUREX HBc IgM assay and Control

FDA Premarket Approval P180045 S009

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 IgM 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 NumberS009 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
PMAP180045
SupplementS009
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 NumberP180045 Supplement NumberS009 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
P180045Original Filing
S011 2022-11-10 30-day Notice
S010
S009 2022-04-05 Real-time Process
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.