PMA P180047S041

Device
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S041
Product code
NCD
Decision date
2025-12-19
Classification
Microbiology
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement
a new supplier has been added for DiaSorin’s accessory

Current openFDA PMA Record#

Device
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S041
Product code
NCD
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date
2025-12-19
Decision code
OK30
Date received
2025-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new supplier has been added for DiaSorin’s accessory