LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg

FDA Premarket Approval P180048 S006

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

To automate a portion of a manual packaging process

DeviceLIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.
Date Received2021-11-23
Decision Date2021-12-17
PMAP180048
SupplementS006
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
P180048Original Filing
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

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