LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab

FDA Premarket Approval P190011 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceLIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantDiaSorin Inc.
Date Received2021-05-27
Decision Date2021-08-10
PMAP190011
SupplementS004
Product CodeMZO 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P190011Original Filing
S004 2021-05-27 Real-time Process
S003
S002 2020-06-18 Real-time Process
S001 2020-02-13 Real-time Process

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