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.
| Device | therascreen KRAS RGQ PCR Kit |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-06-17 |
| PMA | P110027 |
| Supplement | S014 |
| 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 GmbH qiagen Strasse 1 hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Changes To The Instructions For Use (IFU) To Strengthen Information In Relation To Interpretation Of Results For NSCLC Patients To Enhance The Safety Of The QIAGEN Therascreen KRAS RGQ PCR Kit. |
| 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 |