PMA P180049S009

Device: LIAISON® XL MUREX Anti-HBe assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180049
Supplement: S009
Product code: LOM
Decision date: 2022-06-23
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.

Current openFDA PMA Record#

Device: LIAISON® XL MUREX Anti-HBe assay and Control
Applicant: DiaSorin, Inc.
PMA number: P180049
Supplement: S009
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-06-23
Decision code: APPR
Date received: 2022-04-05
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.