LIAISON® XL MUREX HBsAg Qual assay and Control

FDA Premarket Approval P190017 S004

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 HBsAg Qual assay and Control
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantDiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-02-04
Decision Date2022-05-05
PMAP190017
SupplementS004
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin Inc
1951 Northwestern Avenue
stillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
To Allow The LIAISON XL Analyzer To Be Connected To The Beckman DxA 5000, An FDA-cleared Third Party Laboratory Automation System (LAS).

Supplemental Filings

Supplement NumberDateSupplement Type
P190017Original Filing
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.