PMA P190017S027

Device: LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S027
Product code: LOM
Decision date: 2025-08-21
Classification: Microbiology
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: a manufacturing process transfer from one DiaSorin facility to another

Current openFDA PMA Record#

Device: LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S027
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2025-08-21
Decision code: OK30
Date received: 2025-07-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a manufacturing process transfer from one DiaSorin facility to another