PMA P220034S006

Device
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
Applicant
DiaSorin, Inc.
PMA number
P220034
Supplement
S006
Product code
MYL
Decision date
2025-04-10
Classification
Microbiology
Generic name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Approval order statement
to transfer to an alternate facility

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
S006
Product code
MYL
Generic name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Decision date
2025-04-10
Decision code
OK30
Date received
2025-03-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to transfer to an alternate facility