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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 NumberS002
Date Received10/15/2014
Decision Date12/22/2014
Withdrawal Date06/24/2024
Product Code OWD 
Advisory Committee Pathology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING SEVEN CHANGES: CLEANING OF DRIPPING AND SPHERES FILLING EQUIPMENT, TRANSFER OF QUALITY CONTROL ACTIVITIES INTO ANOTHER ROOM, RAW MATERIAL CHANGES FOR BOTTLES AND CAPS FOR THXID-BRAF PUR, MODIFICATION OF A FUNCTIONAL QUALITY CONTROL (QC) TEST FOR THE THXIDTM-BRAF PUR KIT, TRANSFER OF BUFFER MANUFACTURING (FOR THE BRAF PURIFICATION KIT) INTO A NEW BUILDING AT QIAGEN, CHANGES IN DNASE REFERENCE (AM2224) USED IN THE DETERMINATION OF DNASE ACTIVITY IN WATER AND REAGENTS, AND SHELF LIFE EXTENSION FOR RNA TRANSCRIPTS AND PLASMIDS.
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