Approval for: 1) modification of hybridization procedural steps and sequence; this modification entails reversing the addition order of the hpv rna probes and denatured specimen with no change in probe or specimen volume. An additional 10 minute incubation period at room temperature (15 degrees c to 30 degrees c) was added after removal of the specimen from the 65 += 2 degrees c, 60 minutes hybridization incubation step. 2) addition of an equivocal result zone, which requires repeating specimens that have results within this result zone, for specimens collected in preservcyt transport medium. This equivocal result zone has been established to be >=1. 0 and
| Device | HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | QIAGEN GAITHERSBURG, INC |
| Date Received | 2003-10-01 |
| Decision Date | 2003-11-07 |
| PMA | P890064 |
| Supplement | S013 |
| 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