PMA P190017S009

Device: LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test
Applicant: DiaSorin, Inc.
Product code: LOM
Decision date: 2023-04-13
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for removal of repeat testing for samples greater than or equal to 140 s/co by the LIAISON XL MUREX HBsAg Qual assay and removal of testing these samples with LIAISON XL MUREX HBsAg Confirmatory Test.

Current openFDA PMA Record#

Device: LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test
Applicant: DiaSorin, Inc.
PMA number: P190017
Supplement: S009
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2023-04-13
Decision code: APPR
Date received: 2022-10-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for removal of repeat testing for samples greater than or equal to 140 s/co by the LIAISON XL MUREX HBsAg Qual assay and removal of testing these samples with LIAISON XL MUREX HBsAg Confirmatory Test.