FDA.reportPublic FDA data

cobas&#x00AE EZH2 Mutation Test

Primary DI
00875197005592
Brand
cobas&#x00AE EZH2 Mutation Test
Company
Roche Molecular Systems, Inc.
Model
7258321190
Catalog number
07258321190
Published
2020-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWDSomatic gene mutation detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005592008751970055928751970055920875197005592

GMDN Terms#

Term, Definition table
TermDefinition
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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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