AccessGUDID - DEVICE: cobas® EGFR Mutation Test v2 (00875197005448)

GUDID

Device Identifier (DI) Information

Brand Name: cobas® EGFR Mutation Test v2
Version or Model: 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07248563190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005448
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?
58271	Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the EGFR mutation status or mRNA expression of the EGFR gene, 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: 1e75681f-a708-46c8-8db0-4c374ee2d1e0
Public Version Date: February 03, 2021
Public Version Number: 3
DI Record Publish Date: December 16, 2015