PMA P220034S002

Device: LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus
Applicant: DiaSorin, Inc.
PMA number: P220034
Supplement: S002
Product code: MYL
Decision date: 2024-07-12
Classification: Microbiology
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Approval order statement: to change the cleaning process for equipment used to manufacture critical assay components

Current openFDA PMA Record#

Device: LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus
Applicant: DiaSorin, Inc.
PMA number: P220034
Supplement: S002
Product code: MYL
Generic name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
Decision date: 2024-07-12
Decision code: OK30
Date received: 2024-06-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the cleaning process for equipment used to manufacture critical assay components