A software version change to the liaison quantiferon software (lqs)
Device | LIAISON QuantiFERON-TB Gold Plus |
Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
Applicant | DiaSorin, Inc. |
Date Received | 2020-08-25 |
Decision Date | 2020-11-25 |
PMA | P180047 |
Supplement | S006 |
Product Code | NCD |
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 55082-0285 |
Supplemental Filings
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 | | |
NIH GUDID Devices