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 HBc IgM and LIAISON® XL MUREX Control HBc IgM |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-10 |
| Decision Date | 2022-12-08 |
| PMA | P180045 |
| Supplement | S011 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement elimination Of A Manufacturing Step For Kit Component |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180045 | Original Filing | |
| S011 | 2022-11-10 | 30-day Notice |
| S010 | ||
| S009 | 2022-04-05 | Real-time Process |
| S008 | 2022-04-05 | 30-day Notice |
| S007 | 2022-02-04 | Real-time Process |
| S006 | 2021-11-23 | 30-day Notice |
| S005 | 2021-11-23 | 30-day Notice |
| S004 | 2021-11-23 | 30-day Notice |
| S003 | ||
| S002 | 2021-05-27 | Real-time Process |
| S001 |