PMA P220034

Device: LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus
Applicant: DiaSorin, Inc.
Product code: MYL
Decision date: 2026-08-18
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Approval order statement: Approval of the LIAISON diluteX as an accessory to LIAISON XL analyzer for use with the LIAISON Biotrin Parvovirus B19 IgG Plus assay

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: S010
Product code: MYL
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Decision date: 2026-08-18
Decision code: APPR
Date received: 2026-03-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the LIAISON diluteX as an accessory to LIAISON XL analyzer for use with the LIAISON Biotrin Parvovirus B19 IgG Plus assay