PMA P120014S001

Device: THXID-BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S001
Product code: OWD
Decision date: 2015-01-30
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: APPROVAL FOR A NEW DETERMINATION METHOD OF PLASMIDS AND TRANSCRIPTS CONCENTRATION DURING THE MANUFACTURING STEP (FGM/POL/ M00454), BY USING NANODROP UV-VIS SPECTROPHOTOMETER TO CHANGE FROM THE OLD METHOD UTILIZING STANDARD UV-VIS SPECTROPHOTOMETER.

Current openFDA PMA Record#

Device: THXID-BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S001
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2015-01-30
Decision code: APPR
Date received: 2014-10-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW DETERMINATION METHOD OF PLASMIDS AND TRANSCRIPTS CONCENTRATION DURING THE MANUFACTURING STEP (FGM/POL/ M00454), BY USING NANODROP UV-VIS SPECTROPHOTOMETER TO CHANGE FROM THE OLD METHOD UTILIZING STANDARD UV-VIS SPECTROPHOTOMETER.