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.
| Device | LIAISON®XL MUREX Anti-HBc assay and Control |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-05-05 |
| PMA | P180038 |
| Supplement | S010 |
| Product Code | LOM |
| 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 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement To Allow The LIAISON XL Analyzer To Be Connected To The Beckman DxA 5000, An FDA-cleared Third Party Laboratory Automation System (LAS). |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180038 | Original Filing | |
| S014 | 2022-11-10 | 30-day Notice |
| S013 | ||
| S012 | 2022-04-05 | Real-time Process |
| S011 | 2022-04-05 | 30-day Notice |
| S010 | 2022-02-04 | Real-time Process |
| S009 | 2021-11-23 | 30-day Notice |
| S008 | 2021-11-23 | 30-day Notice |
| S007 | 2021-11-23 | 30-day Notice |
| S006 | ||
| S005 | 2021-05-27 | Real-time Process |
| S004 | ||
| S003 | 2020-07-16 | 30-day Notice |
| S002 | 2020-06-18 | Real-time Process |
| S001 | 2020-02-13 | Real-time Process |