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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.
 
DeviceTHERASCREEN KRAS 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 NumberP110027
Supplement NumberS002
Date Received12/15/2014
Decision Date01/15/2015
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
RELOCATION OF THE QUALITY CONTROL LABORATORIES WITHIN QIAGEN MANCHESTER LTD. SKELETON HOUSE FACILITY.
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