LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual

FDA Premarket Approval P190017 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 HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc
Date Received2021-05-27
Decision Date2021-08-10
PMAP190017
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
P190017Original Filing
S010 2022-11-10 30-day Notice
S009
S008 2022-09-21 Real-time Process
S007
S006 2022-04-05 Real-time Process
S005 2022-04-05 30-day Notice
S004 2022-02-04 Real-time Process
S003 2021-11-19 Real-time Process
S002 2021-05-27 Real-time Process
S001

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