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 | HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 1993-09-27 |
| Decision Date | 1995-04-28 |
| PMA | P890064 |
| Supplement | S003 |
| Product Code | MAQ |
| 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 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 |