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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 EGFR RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP120022
Supplement NumberS019
Date Received03/08/2018
Decision Date04/06/2018
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change the supplier and the polymer used for a kit consumable.
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