Software used in combination with the THxIDTM
THxID™ BRAF - 1.0
Device Description
A collection of reagents and other associated materials intended to be used to select treatment options and/or monitor the response to cancer therapy by determining the mutation status of multiple regions of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene in tumour tissue, including codons 464 to 469 and 600, using a nucleic acid technique (NAT).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OWD
Device Name: Somatic Gene Mutation Detection System
Device Class: 3
Physical State: Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
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.
Submission Type ID: 2
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: In vitro amplification and detection of genomic DNA representing a somatic gene mutation from a cancerous specimen of interest.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Human clinical specimens of peripheral blood or bone marrow.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 03573026559823
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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