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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameQIAGEN THERASCREEN KRAS RGQ PCR KIT
Classification Namesomatic gene mutation detection system
ApplicantQIAGEN MANCHESTER LTD
PMA NumberP110027
Supplement NumberS007
Date Received01/26/2015
Decision Date04/24/2015
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product Yes
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.
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