AccessGUDID - DEVICE: THxID™ BRAF (03573026559823)

GUDID

Device Identifier (DI) Information

Brand Name: THxID™ BRAF
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026559823
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58276	BRAF gene mutation IVD, kit, nucleic acid technique (NAT)	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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWD	Somatic Gene Mutation Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120014	001
P120014	002
P120014	003
P120014	004
P120014	005
P120014	006
P120014	007

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ab497ae-054a-494f-82f5-7bc9dcab444b
Public Version Date: June 09, 2025
Public Version Number: 4
DI Record Publish Date: May 12, 2017