PMA P180047S004

Device
LIAISON QuantiFERON - TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S004
Product code
NCD
Decision date
2020-08-06
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement
Approval for software version change to the LIAISON XL analyzer software.

Current openFDA PMA Record#

Device
LIAISON QuantiFERON - TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S004
Product code
NCD
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date
2020-08-06
Decision code
APPR
Date received
2020-06-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software version change to the LIAISON XL analyzer software.