LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus

FDA Premarket Approval P180047 S015

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 and LIAISON® XL Control QuantiFERON-TB Gold Plus
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-05
Decision Date2022-05-06
PMAP180047
SupplementS015
Product CodeNCD 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressDiaSorin, Inc.
1951 Northwestern Avenue
stillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Introduce An Additional Supplier For An Assay Accessory

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing
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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