FDA.reportPublic FDA data

cobas® KRAS Mutation Test

Primary DI
00875197004199
Brand
cobas® KRAS Mutation Test
Company
Roche Molecular Systems, Inc.
Model
1.0
Catalog number
05852170190
Published
2015-07-30
Public version status
Update
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
00875197004199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004199008751970041998751970041990875197004199

GMDN Terms#

Term, Definition table
TermDefinition
KRAS gene mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative detection of the KRAS (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation status and/or to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the KRAS mutation status of tumour tissue using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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