This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| 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 | 1989-11-17 |
| Decision Date | 1991-03-11 |
| Notice Date | 1991-04-10 |
| PMA | P890064 |
| Supplement | S |
| Product Code | MAQ |
| Docket Number | 91M-0108 |
| Advisory Committee | Microbiology |
| 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 |