PMA P220034S008

Device
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus
Applicant
DiaSorin, Inc.
PMA number
P220034
Supplement
S008
Product code
MYL
Decision date
2025-12-19
Classification
Microbiology
Generic name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Approval order statement
a new supplier has been added for DiaSorin’s accessory

Current openFDA PMA Record#

Device
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus
Applicant
DiaSorin, Inc.
PMA number
P220034
Supplement
S008
Product code
MYL
Generic name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Decision date
2025-12-19
Decision code
OK30
Date received
2025-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new supplier has been added for DiaSorin’s accessory