PMA P180047S031

Device
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S031
Product code
NCD
Decision date
2025-01-06
Classification
Microbiology
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Approval order statement
a new piece of equipment required for manufacturing

Current openFDA PMA Record#

Device
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus
Applicant
DiaSorin, Inc.
PMA number
P180047
Supplement
S031
Product code
NCD
Generic name
TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Decision date
2025-01-06
Decision code
OK30
Date received
2024-12-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new piece of equipment required for manufacturing