Approval for a manufacturing site located in penang, malaysia.
| Device | DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 2015-04-28 |
| Decision Date | 2015-05-29 |
| PMA | P890064 |
| Supplement | S032 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
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