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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.
 
DeviceTHXID-BRAF KIT
Generic NameSomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 Anglum Rd.
Hazelwood, MO 63042
PMA NumberP120014
Supplement NumberS006
Date Received01/11/2016
Decision Date04/05/2016
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the THxID-BRAF software to detect a specific fallback threshold value within the SDS file and in such case prevent the generation of a mutation report.
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