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 assay and Control |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD 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 | P180047 |
| Supplement | S016 |
| Product Code | NCD |
| 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 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD 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 |
|---|---|---|
| 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 |