VENTANA HER2 Dual ISH DNA Probe Cocktail

Primary DI
07613336158432
Brand
VENTANA HER2 Dual ISH DNA Probe Cocktail
Company
Ventana Medical Systems, Inc.
Model
08314365001
Catalog number
08314365001
Published
2021-04-09
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 hybridization, 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190031000
P190031004
P190031010
P190031012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190031000HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.2020-07-28NYQ
P190031004HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.2020-07-28NYQ
P190031010HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.2020-07-28NYQ
P190031012HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.2020-07-28NYQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336158432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336158432076133361584327613336158432

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, probeA defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04015630984787SSR Solution06890059001068900590012021-02-03
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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
04015630970155INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.NYQ2014-09-19
05700572032960HER2 CISH pharmDx™ KitAGILENT TECHNOLOGIES SINGAPORE PTE LTDNYQ2014-09-15