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

FDA Premarket Approval P180047 S013

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

To automate a portion of a manual packaging process

DeviceLIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.
Date Received2021-11-23
Decision Date2021-12-17
PMAP180047
SupplementS013
Product CodeNCD 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin, Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing
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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