PMA P190017S003

Device: LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S003
Product code: LOM
Decision date: 2022-01-21
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval to allow an additional supplier of reaction cuvettes used with the assays on the LIAISON XL Analyzer.

Current openFDA PMA Record#

Device: LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S003
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-01-21
Decision code: APPR
Date received: 2021-11-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to allow an additional supplier of reaction cuvettes used with the assays on the LIAISON XL Analyzer.