|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||QIAGEN THERASCREEN KRAS RGQ PCR KIT|
|Classification Name||somatic gene mutation detection system|
|Applicant||QIAGEN MANCHESTER LTD|
|Supplement Type||real-time process|
|Expedited Review Granted?|| 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.