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.
To allow an additional supplier of reaction cuvettes used with the assays on the liaison xl analyzer.
| Device | LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc |
| Date Received | 2021-11-19 |
| Decision Date | 2022-01-21 |
| PMA | P190017 |
| Supplement | S003 |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190017 | Original Filing | |
| S010 | 2022-11-10 | 30-day Notice |
| S009 | ||
| S008 | 2022-09-21 | Real-time Process |
| S007 | ||
| S006 | 2022-04-05 | Real-time Process |
| S005 | 2022-04-05 | 30-day Notice |
| S004 | 2022-02-04 | Real-time Process |
| S003 | 2021-11-19 | Real-time Process |
| S002 | 2021-05-27 | Real-time Process |
| S001 |