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

FDA Premarket Approval P180038 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-HBc and LIAISON® XL MUREX Control Anti-HBc
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS011 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
PMAP180038
SupplementS011
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 NumberP180038 Supplement NumberS011 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
P180038Original Filing
S011 2022-04-05 30-day Notice
S010 2022-02-04 Real-time Process
S009 2021-11-23 30-day Notice
S008 2021-11-23 30-day Notice
S007 2021-11-23 30-day Notice
S006
S005 2021-05-27 Real-time Process
S004
S003 2020-07-16 30-day Notice
S002 2020-06-18 Real-time Process
S001 2020-02-13 Real-time Process

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