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.
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.
| Device | LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | DiaSorin Inc. |
| Date Received | 2021-05-27 |
| Decision Date | 2021-08-10 |
| PMA | P190011 |
| Supplement | S004 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190011 | Original Filing | |
| S004 | 2021-05-27 | Real-time Process |
| S003 | ||
| S002 | 2020-06-18 | Real-time Process |
| S001 | 2020-02-13 | Real-time Process |