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 updates to the limitations section of the instructions for use to include additional cross-reactivity information for the therascreen® egfr rgq pcr kit
| Device | therascreen EGFR RGQ PCR Kit |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN MANCHESTER LTD |
| Date Received | 2019-08-28 |
| Decision Date | 2019-09-26 |
| PMA | P120022 |
| Supplement | S020 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120022 | Original Filing | |
| S022 | 2020-10-23 | Real-time Process |
| S021 | 2020-03-04 | 30-day Notice |
| S020 | 2019-08-28 | Special (immediate Track) |
| S019 | 2018-03-08 | 30-day Notice |
| S018 | 2018-02-16 | Normal 180 Day Track |
| S017 | 2018-01-26 | 30-day Notice |
| S016 | 2017-07-28 | Normal 180 Day Track |
| S015 | 2017-06-29 | 30-day Notice |
| S014 | 2016-12-28 | Normal 180 Day Track |
| S013 | 2016-08-10 | 30-day Notice |
| S012 | 2015-09-28 | Normal 180 Day Track No User Fee |
| S011 | ||
| S010 | 2015-02-18 | Normal 180 Day Track |
| S009 | 2015-01-26 | Real-time Process |
| S008 | 2015-01-26 | Real-time Process |
| S007 | 2015-01-21 | 30-day Notice |
| S006 | 2015-01-21 | 30-day Notice |
| S005 | 2014-12-22 | 30-day Notice |
| S004 | 2014-12-15 | 30-day Notice |
| S003 | ||
| S002 | 2014-11-19 | 30-day Notice |
| S001 | 2014-09-18 | Normal 180 Day Track |