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 | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT |
Classification Name | Kit, Dna Detection, Human Papillomavirus |
Generic Name | Kit, Dna Detection, Human Papillomavirus |
Applicant | QIAGEN GAITHERSBURG, INC |
Date Received | 1991-10-18 |
Decision Date | 1993-05-17 |
PMA | P890064 |
Supplement | S001 |
Product Code | MAQ |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | QIAGEN GAITHERSBURG, INC 1900 Germantown Road germantown, MD 20874 |
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 |
Device ID | PMA | Supp |
---|---|---|
04053228010777 | P890064 | 000 |
04053228002031 | P890064 | 000 |
04053228002024 | P890064 | 000 |
04053228002000 | P890064 | 000 |
14053228002014 | P890064 | 000 |