|
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 | S020 |
Date Received | 08/28/2019 |
Decision Date | 09/26/2019 |
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 updates to the limitations section of the instructions for use to include additional cross-reactivity information for the therascreen® EGFR RGQ PCR Kit. |