AccessGUDID - DEVICE: cobas&#x00AE EZH2 Mutation Test (00875197005592)

GUDID

Device Identifier (DI) Information

Brand Name: cobas&#x00AE EZH2 Mutation Test
Version or Model: 7258321190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07258321190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005592
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):	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?
64643	Enhancer of zeste homolog 2 (EZH2) gene mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to diagnose, monitor or predict the enhancer of zeste homolog 2 (EZH2) gene mutation status of a tumour tissue specimen, using a nucleic acid technique (NAT). This test is intended to be used to monitor the response of follicular lymphoma patients to cancer therapy with an EZH2 inhibitor (e.g., tazemetostat).	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: 1caf27c9-7d57-4d3b-8632-af46f385e636
Public Version Date: August 10, 2020
Public Version Number: 1
DI Record Publish Date: August 01, 2020