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

FDA Premarket Approval P180038 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

Changes allowing harmonization of product qc workflows

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.
Date Received2021-11-23
Decision Date2021-12-27
PMAP180038
SupplementS008
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082

Supplemental Filings

Supplement NumberDateSupplement Type
P180038Original Filing
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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