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.
Approval for replacement of lysis tube in the qiaamp dsp dna ffpe tissue kit.
| Device | QIAGEN THERASCREEN KRAS RGQ PCR KIT |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN MANCHESTER LTD |
| Date Received | 2015-01-26 |
| Decision Date | 2015-04-23 |
| PMA | P110027 |
| Supplement | S006 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110027 | Original Filing | |
| S015 | 2022-06-15 | 30-day Notice |
| S014 | 2022-05-19 | Special (immediate Track) |
| S013 | ||
| S012 | 2021-02-10 | Panel Track |
| S011 | 2020-03-04 | 30-day Notice |
| S010 | 2018-03-08 | 30-day Notice |
| S009 | 2015-08-18 | Normal 180 Day Track No User Fee |
| S008 | 2015-02-18 | Normal 180 Day Track |
| S007 | 2015-01-26 | Real-time Process |
| S006 | 2015-01-26 | Real-time Process |
| S005 | 2015-01-21 | 30-day Notice |
| S004 | 2015-01-21 | 30-day Notice |
| S003 | 2014-12-22 | 30-day Notice |
| S002 | 2014-12-15 | 30-day Notice |
| S001 |