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.
Changes to in-process qc testing
| Device | therascreen PIK3CA RGQ PCR Kit |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN GMBH |
| Date Received | 2020-03-04 |
| Decision Date | 2020-04-03 |
| PMA | P190001 |
| Supplement | S001 |
| Product Code | OWD |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GMBH qiagen Strasse 1 hilden 40724 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190001 | Original Filing | |
| S001 | 2020-03-04 | 30-day Notice |