LIAISON QuantiFERON-TB Gold Plus

FDA Premarket Approval P180047 S006

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

A software version change to the liaison quantiferon software (lqs)

DeviceLIAISON QuantiFERON-TB Gold Plus
Generic NameTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
ApplicantDiaSorin, Inc.
Date Received2020-08-25
Decision Date2020-11-25
PMAP180047
SupplementS006
Product CodeNCD 
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 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P180047Original Filing
S022 2022-11-10 30-day Notice
S021
S020
S019
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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