PMA P190011S002

Device
LIAISON XL MUREX HCV Ab
Applicant
DiaSorin, Inc.
PMA number
P190011
Supplement
S002
Product code
MZO
Decision date
2020-08-06
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement
Approval for software version change to the LIAISON XL analyzer software.

Current openFDA PMA Record#

Device
LIAISON XL MUREX HCV Ab
Applicant
DiaSorin, Inc.
PMA number
P190011
Supplement
S002
Product code
MZO
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date
2020-08-06
Decision code
APPR
Date received
2020-06-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software version change to the LIAISON XL analyzer software.