|
Device | therascreen EGFR RGQ PCR Kit |
Generic Name | somatic gene mutation detection system |
Applicant | QIAGEN GmbH qiagen strasse 1 hilden 40724 |
PMA Number | P120022 |
Supplement Number | S018 |
Date Received | 02/16/2018 |
Decision Date | 09/27/2018 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Clinical Trials | NCT01774721
|
Supplement Type | normal 180 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for to extend the intended use of the therascreen® EGFR RGQ PCR Kit to include the selection of patients with NSCLC for whom dacomitinib is indicated. |