FDA.reportPublic FDA data

INFORM HER2 Dual ISH DNA Probe Cocktail

Primary DI
04015630970155
Brand
INFORM HER2 Dual ISH DNA Probe Cocktail
Company
Ventana Medical Systems, Inc.
Model
50 tests
Published
2014-09-19
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
NYQChromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast CancerUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630970155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630970155040156309701554015630970155

GMDN Terms#

Term, Definition table
TermDefinition
HER2/neu/erbB2 mRNA expression IVD, probeA defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the HER2/neu/erbB2 (v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2) gene in a tumour tissue specimen.

Regulatory Flags#

DUNS number
184042521
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336158432VENTANA HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.NYQ2021-04-09
05700572032960HER2 CISH pharmDx™ KitAGILENT TECHNOLOGIES SINGAPORE PTE LTDNYQ2014-09-15