Approval for a change in the sample conversion protocol for specimens collected in preservcyt solution. The maximum number of specimens that can be processed at one time was increased from 20 to 36 specimens.
| Device | DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 2006-03-24 |
| Decision Date | 2006-04-28 |
| PMA | P890064 |
| Supplement | S018 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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