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 TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OWD

3138Somatic Gene Mutation Detection System

Total Product Life Cycle (TPLC) Devices

3138Somatic Gene Mutation Detection System

Pre-market Approvals for OWD

P120014THxID BRAF assay kitBioMerieux, Inc.
P120022Therascreen EGFR RGQ PCR KitQIAGEN MANCHESTER LTD
P170041Abbott RealTime IDH1Abbott Molecular, Inc.
P160040LeukoStrat CDx FLT3 Mutation AssayINVIVOSCRIBE TECHNOLOGIES, INC
P110020Cobas 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
P120019Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2ROCHE
P140023Cobas KRAS Mutation TestRoche Molecular Systems, Inc.
P110027therascreen KRAS RGQ PCR KitQIAGEN MANCHESTER LTD
P190001therascreen PIK3CA RGQ PCR KitQIAGEN GMBH
P190004therascreen PIK3CA PLASMA RGQ PCR KitQIAGEN GmbH
P170005RealTime IDH2Abbott Molecular Inc.

Global Unique Device Identification Database

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

Maude Adverse Events

THERASCREEN EGFR RGQ PCR KITQIAGEN GMBH2020-03-17
THERASCREEN EGFR RGQ PCR KITQIAGEN GMBH2020-03-17
ABBOTT REALTIME IDH1 AMPLIFICATION REAGENT KITABBOTT MOLECULAR, INC.2020-01-21
COBAS 4800 BRAF V600 MUTATION TESTROCHE MOLECULAR SYSTEMS2017-03-31
COBAS 4800 BRAF V600 MUTATION TESTROCHE MOLECULAR SYSTEMS2017-03-31
THXID? BRAFBIOMERIEUX SA2016-12-28
COBAS EGFR MUTATION TESTROCHE MOLECULAR SYSTEMS2015-01-14
COBAS EGFR MUTATION TESTROCHE MOLECULAR SYSTEMS2014-01-29
COBAS EGFR MUTATION TESTROCHE MOLECULAR SYSTEMS, INC.2014-01-29

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