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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQIAGEN THERASCREEN EGFR RGQ PCR KIT
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
QIAGEN MANCHESTER LTD
skelton house
lloyd street north
manchester M15 6
PMA NumberP120022
Supplement NumberS009
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 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.
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