THXID BRAF KIT
FDA premarket approval P120014/S002 · decided 2014-12-22
Approval details
- PMA number
- P120014
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THXID BRAF KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- bioMerieux, Inc.
- Date received
- 2014-10-15
- Decision date
- 2014-12-22
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hazelwood, MO
- 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, AN
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