Approval for the upgrade of the hc2 software suite to version 4. 2.
Device | DIGENE HC2 STSTEM SOFTWARE |
Classification Name | Kit, Dna Detection, Human Papillomavirus |
Generic Name | Kit, Dna Detection, Human Papillomavirus |
Applicant | QIAGEN GAITHERSBURG, INC |
Date Received | 2014-03-21 |
Decision Date | 2014-05-12 |
PMA | P890064 |
Supplement | S030 |
Product Code | MAQ |
Advisory Committee | Microbiology |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | QIAGEN GAITHERSBURG, INC 1900 Germantown Road germantown, MD 20874 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P890064 | | Original Filing |
S041 |
2020-05-20 |
30-day Notice |
S040 |
2018-02-28 |
30-day Notice |
S039 |
2018-02-16 |
30-day Notice |
S038 |
2018-02-16 |
30-day Notice |
S037 |
2018-01-26 |
30-day Notice |
S036 |
2018-01-11 |
30-day Notice |
S035 |
2017-11-30 |
30-day Notice |
S034 |
2017-06-29 |
30-day Notice |
S033 |
2016-02-19 |
Real-time Process |
S032 |
2015-04-28 |
Normal 180 Day Track No User Fee |
S031 |
2014-09-23 |
Real-time Process |
S030 |
2014-03-21 |
Real-time Process |
S029 |
2013-08-15 |
Normal 180 Day Track No User Fee |
S028 | | |
S027 |
2011-07-28 |
Normal 180 Day Track No User Fee |
S026 |
2011-02-28 |
Real-time Process |
S025 |
2011-02-28 |
30-day Notice |
S024 |
2010-04-15 |
30-day Notice |
S023 |
2010-04-15 |
30-day Notice |
S022 |
2010-04-15 |
30-day Notice |
S021 |
2010-02-03 |
Normal 180 Day Track No User Fee |
S020 |
2008-01-29 |
Normal 180 Day Track No User Fee |
S019 | | |
S018 |
2006-03-24 |
Real-time Process |
S017 |
2004-11-19 |
Special (immediate Track) |
S016 | | |
S015 |
2004-05-28 |
Real-time Process |
S014 |
2003-11-05 |
Normal 180 Day Track |
S013 |
2003-10-01 |
Real-time Process |
S012 |
2003-05-20 |
Special (immediate Track) |
S011 | | |
S010 | | |
S009 |
2001-10-01 |
Panel Track |
S008 |
2000-08-25 |
Normal 180 Day Track |
S007 |
2000-02-07 |
Normal 180 Day Track |
S006 |
1997-09-30 |
Normal 180 Day Track |
S005 |
1996-11-01 |
Normal 180 Day Track |
S004 |
1996-05-03 |
Normal 180 Day Track |
S003 |
1993-09-27 |
Normal 180 Day Track |
S002 |
1992-12-09 |
Normal 180 Day Track |
S001 |
1991-10-18 |
Normal 180 Day Track |
NIH GUDID Devices