LIAISON® QuantiFERON TB-Gold Plus assay and Control

FDA Premarket Approval P180047 S017

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® QuantiFERON TB-Gold Plus assay and Control
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-13
Decision Date2022-07-08
PMAP180047
SupplementS017
Product CodeNCD 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin, Inc.
1951 Northwestern Avenue
stillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For A Software Version Change To The LIAISON XS Software.

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing
S018 2022-07-15 30-day Notice
S017 2022-04-13 Real-time Process
S016 2022-04-05 Real-time Process
S015 2022-04-05 30-day Notice
S014 2022-02-04 Real-time Process
S013 2021-11-23 30-day Notice
S012
S011
S010 2021-05-27 Real-time Process
S009
S008
S007
S006 2020-08-25 Real-time Process
S005 2020-07-16 30-day Notice
S004 2020-06-18 Real-time Process
S003 2020-06-04 Real-time Process
S002 2020-02-13 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
08056771103572 P180047 000
08056771103275 P180047 000
08056771103268 P180047 000

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