|
Device | therascreen KRAS RGQ PCR Kit |
Generic Name | Somatic gene mutation detection system |
Applicant | QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 |
PMA Number | P110027 |
Supplement Number | S014 |
Date Received | 05/19/2022 |
Decision Date | 06/17/2022 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |