PMA P180038S024

Device: LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc
Applicant: DiaSorin, Inc.
PMA number: P180038
Supplement: S024
Product code: LOM
Decision date: 2025-06-04
Classification: Microbiology
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for additional Cuvettes supplier and the refinement of a few geometric tolerances of the cuvettes in bulk.

Current openFDA PMA Record#

Device: LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc
Applicant: DiaSorin, Inc.
PMA number: P180038
Supplement: S024
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2025-06-04
Decision code: APPR
Date received: 2025-03-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for additional Cuvettes supplier and the refinement of a few geometric tolerances of the cuvettes in bulk.