PMA P180049S007

Device: LIAISON® XL MUREX Anti-HBe assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180049
Supplement: S007
Product code: LOM
Decision date: 2022-05-05
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval to allow the LIAISON XL Analyzer to be connected to the Beckman DxA 5000, an FDA-cleared third party Laboratory Automation System (LAS).

Current openFDA PMA Record#

Device: LIAISON® XL MUREX Anti-HBe assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180049
Supplement: S007
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-05-05
Decision code: APPR
Date received: 2022-02-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to allow the LIAISON XL Analyzer to be connected to the Beckman DxA 5000, an FDA-cleared third party Laboratory Automation System (LAS).