PMA P220034S007

Device: LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus
Applicant: DiaSorin, Inc.
PMA number: P220034
Supplement: S007
Product code: MYL
Decision date: 2025-10-10
Classification: Microbiology
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Approval order statement: Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents

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: S007
Product code: MYL
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Decision date: 2025-10-10
Decision code: APPR
Date received: 2025-07-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of an alternative polypropylene resin for production of the plastic vials hosting the LIAISON assays reagents