Approval for a design change to the device tb antigen blood collection tubes.
Device | QUANTTFERON-TB GOLD Plus |
Classification Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
Applicant | QIAGEN |
Date Received | 2016-12-09 |
Decision Date | 2017-06-07 |
PMA | P010033 |
Supplement | S031 |
Product Code | NCD |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track |
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