|
Device | QIAGEN 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 | S016 |
Date Received | 09/06/2023 |
Decision Date | 10/06/2023 |
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 an update to the Instructions For Use to strengthen information in relation to interpretation of results for patients with colorectal cancer and non-small cell lung cancer to enhance the safety of the QIAGEN therascreen KRAS RGQ PCR Kit. |