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® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD 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 | P180047 |
| Supplement | S022 |
| Product Code | NCD |
| 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 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD 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 |
|---|---|---|
| P180047 | Original Filing | |
| S022 | 2022-11-10 | 30-day Notice |
| S021 | ||
| S020 | ||
| S019 | ||
| S018 | 2022-07-15 | 30-day Notice |
| S017 | 2022-04-13 | Real-time Process |
| S016 | 2022-04-05 | Real-time Process |
| S015 | 2022-04-05 | 30-day Notice |
| S014 | 2022-02-04 | Real-time Process |
| S013 | 2021-11-23 | 30-day Notice |
| S012 | ||
| S011 | ||
| S010 | 2021-05-27 | Real-time Process |
| S009 | ||
| S008 | ||
| S007 | ||
| S006 | 2020-08-25 | Real-time Process |
| S005 | 2020-07-16 | 30-day Notice |
| S004 | 2020-06-18 | Real-time Process |
| S003 | 2020-06-04 | Real-time Process |
| S002 | 2020-02-13 | Real-time Process |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 08056771103572 | P180047 | 000 |
| 08056771103275 | P180047 | 000 |
| 08056771103268 | P180047 | 000 |