|
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 |
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. |