PMA P220034S011
- Device
- LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P220034
- Supplement
- S011
- Product code
- MYL
- Decision date
- 2026-06-24
- Classification
- Microbiology
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- implement a manufacturing process scale up
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
- S011
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2026-06-24
- Decision code
- OK30
- Date received
- 2026-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implement a manufacturing process scale up