AccessGUDID - DEVICE: cobas® 4800 BRAF V600 Mutation Test (00875197004137)

GUDID

Device Identifier (DI) Information

Brand Name: cobas® 4800 BRAF V600 Mutation Test
Version or Model: 05985579190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05985579190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197004137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *Terms of Use

Device Description: No description.

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):	No
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 [?]
Premarket Submission Number Not Available/Not Released

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: f2a8a763-9d9c-41c4-823c-548b37ca9060
Public Version Date: June 09, 2025
Public Version Number: 3
DI Record Publish Date: September 10, 2014