PMA P180047

Device
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S022
Product code
NCD
Decision date
2026-05-26
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement
the use of a Cleaning Tool on another instrument

Current openFDA PMA Record#

Device
LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S044
Product code
NCD
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date
2026-05-26
Decision code
OK30
Date received
2026-04-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the use of a Cleaning Tool on another instrument