|Trade Name||THERASCREEN EGFR RGQ PCR KIT|
|Classification Name||somatic gene mutation detection system|
|Applicant||QIAGEN MANCHESTER LTD|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change of filling process for proteinase k in the qiaamp dsp dna ffpe tissue kit from a manual to an automated process at the hilden, germany facility.