PMA P190011

Device: LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab
Applicant: DiaSorin, Inc.
PMA number: P190011
Supplement: S004
Product code: MZO
Decision date: 2021-08-10
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: Approval for a software version change for the LIAISON XL Analyzer from the approved LIAISON XL version 4.2.2.3 SP1 to software version 4.2.2.4.

Current openFDA PMA Record#

Device: LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab
Applicant: DiaSorin, Inc.
PMA number: P190011
Supplement: S004
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2021-08-10
Decision code: APPR
Date received: 2021-05-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software version change for the LIAISON XL Analyzer from the approved LIAISON XL version 4.2.2.3 SP1 to software version 4.2.2.4.