Somatic Gene Mutation Detection System

Product Code: OWD

In Vitro And Other Medical Laser Products

Definition: The Somatic Gene Mutation Detection System Is An In Vitro Diagnostic Nucleic Acid Amplification And Real-time Detection System For The Identification Of Genetic Mutations In Dna Extracted From Human Tumor Tissues.

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations:

• Radiation Type: Optical
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as OWD

3138

Somatic Gene Mutation Detection System

Total Product Life Cycle (TPLC) Devices

3138

Somatic Gene Mutation Detection System

Pre-market Approvals for OWD

P120014	THxID BRAF assay kit	BioMerieux, Inc.
P120022	Therascreen EGFR RGQ PCR Kit	QIAGEN MANCHESTER LTD
P170041	Abbott RealTime IDH1	Abbott Molecular, Inc.
P160040	LeukoStrat CDx FLT3 Mutation Assay	INVIVOSCRIBE TECHNOLOGIES, INC
P120019	Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2	ROCHE
P140023	Cobas KRAS Mutation Test	Roche Molecular Systems, Inc.
P110020	Cobas 4800 BRAF V600 Mutation Test	Roche Molecular Systems, Inc.
P110027	therascreen KRAS RGQ PCR Kit	QIAGEN MANCHESTER LTD
P190001	therascreen PIK3CA RGQ PCR Kit	QIAGEN GMBH
P190004	therascreen PIK3CA PLASMA RGQ PCR Kit	QIAGEN GmbH
P170005	RealTime IDH2	Abbott Molecular Inc.

Global Unique Device Identification Database

• 00884999047792: Somatic gene mutation detection system
• 00884999047358: Somatic gene mutation detection system
• 00884999047341: Somatic gene mutation detection system
• 00884999047051: Somatic gene mutation detection system
• 00884999047044: Somatic gene mutation detection system
• 00884999047037: Somatic gene mutation detection system
• 00875197005448: Somatic gene mutation detection system
• 00875197004229: Somatic gene mutation detection system
• 00875197004199: Somatic gene mutation detection system
• 00875197004137: Somatic gene mutation detection system
• 00875197004120: Somatic gene mutation detection system
• 04053228002062: Somatic Gene Mutation Detection System
• 04053228002048: Somatic Gene Mutation Detection System
• 04053228034094: Somatic Gene Mutation Detection System
• 04053228034223: Somatic Gene Mutation Detection System

Maude Adverse Events

THERASCREEN EGFR RGQ PCR KIT	QIAGEN GMBH	2020-03-17
THERASCREEN EGFR RGQ PCR KIT	QIAGEN GMBH	2020-03-17
ABBOTT REALTIME IDH1 AMPLIFICATION REAGENT KIT	ABBOTT MOLECULAR, INC.	2020-01-21
COBAS 4800 BRAF V600 MUTATION TEST	ROCHE MOLECULAR SYSTEMS	2017-03-31
COBAS 4800 BRAF V600 MUTATION TEST	ROCHE MOLECULAR SYSTEMS	2017-03-31
THXID? BRAF	BIOMERIEUX SA	2016-12-28
COBAS EGFR MUTATION TEST	ROCHE MOLECULAR SYSTEMS	2015-01-14
COBAS EGFR MUTATION TEST	ROCHE MOLECULAR SYSTEMS	2014-01-29
COBAS EGFR MUTATION TEST	ROCHE MOLECULAR SYSTEMS, INC.	2014-01-29