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 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 NumberP180045 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-05 |
| Decision Date | 2022-06-23 |
| PMA | P180045 |
| Supplement | S009 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| 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 NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Addition Of The Alternate Supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), To Produce Vial And Frame Plastics Components Of The Reagent Integral. |
| 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 |