PMA P180039S001

Device
LIAISON XL MUREX Anti-HBs
Applicant
DiaSorin, Inc.
PMA number
P180039
Supplement
S001
Product code
LOM
Decision date
2020-08-06
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Approval for software version change to the LIAISON XL analyzer software.

Current openFDA PMA Record#

Device
LIAISON XL MUREX Anti-HBs
Applicant
DiaSorin, Inc.
PMA number
P180039
Supplement
S001
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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.