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HercepTest™ for Automated Link Plarforms

Primary DI
05700572032007
Brand
HercepTest™ for Automated Link Plarforms
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
SK001
Device description
HercepTest for Automated Link Platforms
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVCSystem, Test, Her-2/Neu, Ihc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVCSystem, Test, Her-2/Neu, IhcUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980018000DAKO HERCEPTESTAgilent Technologies Singapore (International) Pte , Ltd.1998-09-25MVC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572032007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572032007057005720320075700572032007

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Store in the dark
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572033028DakoGA6332026-05-15
05700572033127DakoGA6142026-05-16
05700572033363DakoGA6282026-05-15
05700572034230DakoGA6272026-05-16
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209M07582020-09-17
05700574035631Alissa InterpretK5849AA2022-07-11
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
05700575014031Dako Omnis Waste Tank (NHz)GC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16
05700575000416Dako Omnis 165 DuoGI1002025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847627041999HER2/neu [IHC042]BIOCARE MEDICAL LLCMVC2025-12-16
05055331301291BOND ORACLE HER2 IHC SystemLEICA BIOSYSTEMS NEWCASTLE LTDMVC2014-09-23
04015630972289PATHWAY HER-2 4 in 1 Control SlidesVentana Medical Systems, Inc.MVC2014-09-16
05700572031987HercepTest™AGILENT TECHNOLOGIES SINGAPORE PTE LTDMVC2014-09-15
05700572031994HercepTest™ for the Dako AutostainerAGILENT TECHNOLOGIES SINGAPORE PTE LTDMVC2014-09-15
04015630972197PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.MVC2014-09-11