FDA.reportPublic FDA data

cobas® 4800 BRAF V600 Mutation Test

Primary DI
00875197004137
Brand
cobas® 4800 BRAF V600 Mutation Test
Company
Roche Molecular Systems, Inc.
Model
05985579190
Catalog number
05985579190
Published
2014-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00875197004137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004137008751970041378751970041370875197004137

GMDN Terms#

Term, Definition table
TermDefinition
BRAF V600 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 V600 mutation status of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene e.g., (V600A, V600D, V600E, V600K and V600R) in 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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