LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe

FDA Premarket Approval P180049 S002

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

Approval for a software version change for the liaison xl analyzer from the approved liaison xl version 4. 2. 2. 3 sp1 to software version 4. 2. 2. 4.

DeviceLIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc.
Date Received2021-05-27
Decision Date2021-08-10
PMAP180049
SupplementS002
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082

Supplemental Filings

Supplement NumberDateSupplement Type
P180049Original Filing
S008 2022-04-05 30-day Notice
S007 2022-02-04 Real-time Process
S006 2021-11-23 30-day Notice
S005
S004 2021-11-23 30-day Notice
S003
S002 2021-05-27 Real-time Process
S001

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