PMA P180039S013

Device
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Applicant
DiaSorin, Inc.
PMA number
P180039
Supplement
S013
Decision date
2022-12-08
Approval order statement
Elimination of a manufacturing step for kit component.

Current openFDA PMA Record#

Device
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
Applicant
DiaSorin, Inc.
PMA number
P180039
Supplement
S013
Decision date
2022-12-08
Decision code
OK30
Date received
2022-11-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Elimination of a manufacturing step for kit component.