PMA P190011S001
- Device
- LIAISON XL MUREX HCV Ab
- Applicant
- DiaSorin, Inc.
- PMA number
- P190011
- Supplement
- S001
- Product code
- MZO
- Decision date
- 2020-04-08
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Approval for System software update from software version 4.2.1.1 to software version 4.2.2.2 on the LIAISONĀ® XL analyzer.
Current openFDA PMA Record#
- Device
- LIAISON XL MUREX HCV Ab
- Applicant
- DiaSorin, Inc.
- PMA number
- P190011
- Supplement
- S001
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2020-04-08
- Decision code
- APPR
- Date received
- 2020-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for System software update from software version 4.2.1.1 to software version 4.2.2.2 on the LIAISONĀ® XL analyzer.