AccessGUDID - DEVICE: THxID™-BRAF (03573026354909)

GUDID

Device Identifier (DI) Information

Brand Name: THxID™-BRAF
Version or Model: 410697
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 410697
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026354909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue

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:	Yes
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	000
P120014	001
P120014	002
P120014	003
P120014	004
P120014	005
P120014	006
P120014	007
P120014	008
P120014	009
P120014	010
P120014	011
P120014	012

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b000a1f-4104-4eaf-a589-289edd1b4fa4
Public Version Date: June 09, 2025
Public Version Number: 8
DI Record Publish Date: September 23, 2014