PMA P120014S006

Device: THXID-BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S006
Product code: OWD
Decision date: 2016-04-05
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
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.

Current openFDA PMA Record#

Device: THXID-BRAF KIT
Applicant: bioMerieux, Inc.
PMA number: P120014
Supplement: S006
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2016-04-05
Decision code: APPR
Date received: 2016-01-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.