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, LIAISON 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 NumberS018 Date Received07/15/2022 Decision Date08/11/2022 Product Code NCD Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-07-15 |
Decision Date | 2022-08-11 |
PMA | P180047 |
Supplement | S018 |
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 NumberS018 Date Received07/15/2022 Decision Date08/11/2022 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 the Transfer Of Manufacturing Activities For An Instrument 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 |