PMA P190017S026

Device: LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S026
Product code: LOM
Decision date: 2025-10-10
Classification: Microbiology
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S026
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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