Approval for change in critical raw material of kit component.
| Device | QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test |
| Classification Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | QIAGEN |
| Date Received | 2018-09-25 |
| Decision Date | 2018-10-30 |
| PMA | P010033 |
| Supplement | S041 |
| 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 | QIAGEN 19300 Germantown Road germantown, MD 20874 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010033 | | Original Filing |
| S048 |
2022-09-30 |
Real-time Process |
| S047 |
2021-03-26 |
Normal 180 Day Track |
| S046 |
2019-11-06 |
30-day Notice |
| S045 |
2019-04-15 |
Real-time Process |
| S044 |
2019-04-04 |
30-day Notice |
| S043 |
2019-02-15 |
30-day Notice |
| S042 |
2018-12-13 |
30-day Notice |
| S041 |
2018-09-25 |
Real-time Process |
| S040 |
2018-09-07 |
30-day Notice |
| S039 |
2018-02-28 |
30-day Notice |
| S038 |
2018-01-26 |
30-day Notice |
| S037 |
2018-01-11 |
135 Review Track For 30-day Notice |
| S036 |
2017-11-13 |
30-day Notice |
| S035 |
2017-10-31 |
30-day Notice |
| S034 |
2017-05-24 |
30-day Notice |
| S033 |
2017-04-12 |
30-day Notice |
| S032 |
2017-02-06 |
30-day Notice |
| S031 |
2016-12-09 |
Normal 180 Day Track |
| S030 |
2016-07-28 |
30-day Notice |
| S029 |
2016-07-21 |
30-day Notice |
| S028 |
2016-03-25 |
30-day Notice |
| S027 | | |
| S026 |
2014-11-10 |
30-day Notice |
| S025 |
2014-10-24 |
Normal 180 Day Track No User Fee |
| S024 |
2014-04-23 |
30-day Notice |
| S023 |
2013-12-23 |
30-day Notice |
| S022 | | |
| S021 | | |
| S020 |
2012-04-11 |
Normal 180 Day Track |
| S019 |
2011-08-04 |
Special (immediate Track) |
| S018 |
2011-02-23 |
30-day Notice |
| S017 |
2010-08-30 |
Special (immediate Track) |
| S016 |
2010-05-20 |
135 Review Track For 30-day Notice |
| S015 |
2009-06-10 |
135 Review Track For 30-day Notice |
| S014 |
2009-06-02 |
135 Review Track For 30-day Notice |
| S013 |
2008-06-10 |
Real-time Process |
| S012 |
2007-03-16 |
Normal 180 Day Track No User Fee |
| S011 |
2006-06-01 |
Normal 180 Day Track |
| S010 |
2006-02-14 |
Special (immediate Track) |
| S009 |
2005-11-22 |
Normal 180 Day Track No User Fee |
| S008 | | |
| S007 |
2004-01-14 |
30-day Notice |
| S006 |
2003-12-04 |
Normal 180 Day Track |
| S005 |
2003-04-18 |
30-day Notice |
| S004 |
2003-02-28 |
Real-time Process |
| S003 |
2003-02-20 |
Special (immediate Track) |
| S002 |
2002-12-02 |
30-day Notice |
| S001 |
2002-10-07 |
30-day Notice |
NIH GUDID Devices