|
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 | S007 |
Date Received | 01/26/2015 |
Decision Date | 04/24/2015 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACEMENT OF THE RAW MATERIALS USED IN MANUFACTURING OF PRIMARY PACKAGING (BOTTLES AND CAPS) FOR BUFFERS IN THE QIAAMP DSP DNA FFPE TISSUE KIT. |