PMA P120014S002

Device: THXID BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S002
Product code: OWD
Decision date: 2014-12-22
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
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.

Current openFDA PMA Record#

Device: THXID BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S002
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2014-12-22
Decision code: APPR
Date received: 2014-10-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.