{
"ProductData": {
"ID": "RTD000783",
"ProductType": "Others",
"BrandName": "CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody",
"ProductNameAddition": "",
"RegulatoryDisclaimer1": "For in vitro diagnostic use.",
"DisclaimerGroup1": "IVD",
"RegulatoryDisclaimer2": null,
"DisclaimerGroup2": null,
"RegulatoryDisclaimer3": null,
"SampleType": [
"Formalin-Fixed Paraffin-Embedded Tissue (FFPET)"
],
"LicenseDisclaimers": [
],
"RelatedLinks": "",
"Clone": "5B7",
"ControlTissue": [
"Non Small Cell Lung Carcinoma",
"Placenta",
"Skin"
],
"ISOtypes": "",
"Species": [
"Rabbit"
],
"StainLocalization": [
"Cytoplasm",
"Membrane"
],
"ProductNameGlobal": "Epidermal Growth Factor Receptor 5B7 CONFIRM"
},
"ProductImageDetails": {
"ImagePath": "https://pim-media.roche.com/Images/Product_RTD000783_im_en.jpg",
"ImageType": "Image main"
},
"Product2Taxonomy": {
"Product2TaxonomyReferences": [
{
"StructureSystemIdentifier": "Product_Grouping",
"StructureSystemName": "Product Grouping",
"NodeID": "05-0002",
"StructureNodeStatus": "Active",
"NodeName": "IHC Primary Antibodies"
},
{
"StructureSystemIdentifier": "OWP_Family",
"StructureSystemName": "Product Families",
"NodeID": "130",
"StructureNodeStatus": "Active",
"NodeName": "CONFIRM"
},
{
"StructureSystemIdentifier": "OWP_Techniques",
"StructureSystemName": "Techniques",
"NodeID": "073-00",
"StructureNodeStatus": "Active",
"NodeName": "Immunohistochemistry (IHC)"
},
{
"StructureSystemIdentifier": "Lab_Type",
"StructureSystemName": "Lab Types",
"NodeID": "080-00",
"StructureNodeStatus": "Active",
"NodeName": "Pathology Lab"
},
{
"StructureSystemIdentifier": "Health_Topics",
"StructureSystemName": "Health Topics",
"NodeID": "19-00-00",
"StructureNodeStatus": "Active",
"NodeName": "Oncology"
},
{
"StructureSystemIdentifier": "Disease_Areas",
"StructureSystemName": "Disease Areas",
"NodeID": "23-00-00",
"StructureNodeStatus": "Active",
"NodeName": "Lung cancer"
},
{
"StructureSystemIdentifier": "Health_Topics",
"StructureSystemName": "Health Topics",
"NodeID": "20-00-00",
"StructureNodeStatus": "Active",
"NodeName": "Pulmonology"
},
{
"StructureSystemIdentifier": "Product_Solutions",
"StructureSystemName": "Product Solutions",
"NodeID": "010",
"StructureNodeStatus": "Active",
"NodeName": "Histopathology"
},
{
"StructureSystemIdentifier": "Applications",
"StructureSystemName": "Applications",
"NodeID": "99-00-00",
"StructureNodeStatus": "Inactive",
"NodeName": ""
},
{
"StructureSystemIdentifier": "Pathogens",
"StructureSystemName": "Pathogens",
"NodeID": "99-00-00",
"StructureNodeStatus": "Inactive",
"NodeName": ""
},
{
"StructureSystemIdentifier": "OWP_Product_Types",
"StructureSystemName": "Product Types",
"NodeID": "15-000-00",
"StructureNodeStatus": "Active",
"NodeName": "Primary Antibody"
},
{
"StructureSystemIdentifier": "OWP_Family",
"StructureSystemName": "Product Families",
"NodeID": "080",
"StructureNodeStatus": "Active",
"NodeName": "BenchMark"
}
]
},
"Product2Materials": {
"P2MaterialReferences": [
{
"MaterialNum": "05278457001",
"MaterialDescription": "CONFIRM ANTI-EGFR (5B7) RABBIT MONOCLONA",
"RegisteredProductName": "CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody",
"GTIN": "04015630972357",
"ProductCategoryText": "Reagents, kits",
"OldMaterialNumber": "790-4347",
"PackSizePIM360": "50 tests",
"PackSizeDescPIM360": "Not Available",
"MaterialAnnotation": "",
"ReadyForUse": "true",
"OrderInformation": ""
}
]
},
"Product2Products": {
"Product2ProductReference": [
{
"ProductID": "INS_2099",
"BrandName": "BenchMark ULTRA",
"ProductNameAddition": "",
"ReferenceType": "Instrument",
"Classification": [
{
"IdentifierofStructureSystem": "1",
"NameofStructureSystem": "GPCH",
"StructureNodeID": "2300",
"StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark ULTRA",
"StructureGroupName": "BenchMark ULTRA",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Product_Types",
"NameofStructureSystem": "Product Types",
"StructureNodeID": "10-000-00",
"StructureGroupPath": "Analyzer Instruments and Systems",
"StructureGroupName": "Analyzer Instruments and Systems",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Family",
"NameofStructureSystem": "Product Families",
"StructureNodeID": "080",
"StructureGroupPath": "BenchMark",
"StructureGroupName": "BenchMark",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Lab_Type",
"NameofStructureSystem": "Lab Types",
"StructureNodeID": "080-00",
"StructureGroupPath": "Pathology Lab",
"StructureGroupName": "Pathology Lab",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Product_Solutions",
"NameofStructureSystem": "Product Solutions",
"StructureNodeID": "010",
"StructureGroupPath": "Histopathology",
"StructureGroupName": "Histopathology",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Techniques",
"NameofStructureSystem": "Techniques",
"StructureNodeID": "073-00",
"StructureGroupPath": "Immunohistochemistry (IHC)",
"StructureGroupName": "Immunohistochemistry (IHC)",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Techniques",
"NameofStructureSystem": "Techniques",
"StructureNodeID": "075-00",
"StructureGroupPath": "In situ Hybridization (ISH)",
"StructureGroupName": "In situ Hybridization (ISH)",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Applications",
"NameofStructureSystem": "Applications",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Disease_Areas",
"NameofStructureSystem": "Disease Areas",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Pathogens",
"NameofStructureSystem": "Pathogens",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Health_Topics",
"NameofStructureSystem": "Health Topics",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
}
]
},
{
"ProductID": "INS_2580",
"BrandName": "BenchMark GX",
"ProductNameAddition": "",
"ReferenceType": "Instrument",
"Classification": [
{
"IdentifierofStructureSystem": "1",
"NameofStructureSystem": "GPCH",
"StructureNodeID": "6151",
"StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark GX",
"StructureGroupName": "BenchMark GX",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Product_Types",
"NameofStructureSystem": "Product Types",
"StructureNodeID": "10-000-00",
"StructureGroupPath": "Analyzer Instruments and Systems",
"StructureGroupName": "Analyzer Instruments and Systems",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Family",
"NameofStructureSystem": "Product Families",
"StructureNodeID": "080",
"StructureGroupPath": "BenchMark",
"StructureGroupName": "BenchMark",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Lab_Type",
"NameofStructureSystem": "Lab Types",
"StructureNodeID": "080-00",
"StructureGroupPath": "Pathology Lab",
"StructureGroupName": "Pathology Lab",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Product_Solutions",
"NameofStructureSystem": "Product Solutions",
"StructureNodeID": "010",
"StructureGroupPath": "Histopathology",
"StructureGroupName": "Histopathology",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Techniques",
"NameofStructureSystem": "Techniques",
"StructureNodeID": "999-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Applications",
"NameofStructureSystem": "Applications",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Disease_Areas",
"NameofStructureSystem": "Disease Areas",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Pathogens",
"NameofStructureSystem": "Pathogens",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Health_Topics",
"NameofStructureSystem": "Health Topics",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
}
]
},
{
"ProductID": "RTD001185",
"BrandName": "ultraView Universal DAB Detection Kit",
"ProductNameAddition": "",
"ReferenceType": "Reagent",
"Classification": [
{
"IdentifierofStructureSystem": "Product_Grouping",
"NameofStructureSystem": "Product Grouping",
"StructureNodeID": "05-0001",
"StructureGroupPath": "Tissue->IHC Detection Systems",
"StructureGroupName": "IHC Detection Systems",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Product_Types",
"NameofStructureSystem": "Product Types",
"StructureNodeID": "20-000-00",
"StructureGroupPath": "Assays Reagents and Strips",
"StructureGroupName": "Assays Reagents and Strips",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Techniques",
"NameofStructureSystem": "Techniques",
"StructureNodeID": "073-00",
"StructureGroupPath": "Immunohistochemistry (IHC)",
"StructureGroupName": "Immunohistochemistry (IHC)",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Lab_Type",
"NameofStructureSystem": "Lab Types",
"StructureNodeID": "080-00",
"StructureGroupPath": "Pathology Lab",
"StructureGroupName": "Pathology Lab",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Product_Solutions",
"NameofStructureSystem": "Product Solutions",
"StructureNodeID": "010",
"StructureGroupPath": "Histopathology",
"StructureGroupName": "Histopathology",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "Applications",
"NameofStructureSystem": "Applications",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Health_Topics",
"NameofStructureSystem": "Health Topics",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Disease_Areas",
"NameofStructureSystem": "Disease Areas",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "Pathogens",
"NameofStructureSystem": "Pathogens",
"StructureNodeID": "99-00-00",
"StructureGroupPath": "",
"StructureGroupName": "",
"StructureNodeStatus": "Inactive"
},
{
"IdentifierofStructureSystem": "OWP_Family",
"NameofStructureSystem": "Product Families",
"StructureNodeID": "660",
"StructureGroupPath": "ultraView",
"StructureGroupName": "ultraView",
"StructureNodeStatus": "Active"
},
{
"IdentifierofStructureSystem": "OWP_Family",
"NameofStructureSystem": "Product Families",
"StructureNodeID": "410",
"StructureGroupPath": "VENTANA",
"StructureGroupName": "VENTANA",
"StructureNodeStatus": "Active"
}
]
}
]
},
"ProductSpec": [
{
"ProductSpecVariant": {
"Chapters": [
{
"Name": "Storage Conditions (Product)",
"Value": "Store at 2-8° C. Do not freeze.",
"Language": "en",
"Country": "XG",
"Code": "Storage Conditions (Product)"
},
{
"Name": "Content",
"Value": "CONFIRM anti-EGFR (5B7) contains sufficient reagent for staining 50 slides.
One 5 mL dispenser of CONFIRM anti-EGFR (5B7) contains approximately 2 μg of a rabbit monoclonal antibody.
The antibody is diluted in 0.05 M Tris-HCI with 2% carrier protein, and 0.10% ProClin® 300, a preservative containing the active ingredients 5-chloro-2-methyl-4-isothiazolin-3- one and 2-methyl-4-isothiazolin-3-one.
Total protein concentration of the reagent is approximately 10.5 μg/ mL.
Specific antibody concentration is approximately 0.4 μg/ mL. There is no known irrelevant antibody reactivity observed in this product.
There is a trace (~2%) of fetal calf serum of U.S. origin from the stock solution.
Refer to the appropriate Ventana detection kit package insert for detailed descriptions of: (1) Principles and Procedures, (2) Materials and Reagents Needed but Not Provided, (3) Specimen Preparation, (4) Quality Control, (5) Troubleshooting, (6) Interpretation of Staining, and (7) General Limitations.",
"Language": "en",
"Country": "XG",
"Code": "Content"
},
{
"Name": "Intended Use",
"Value": "This antibody is intended for in vitro diagnostic (IVD) use.
Ventana Medical Systems’ (Ventana) CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Antibody is a primary antibody designed to qualitatively detect the presence of the internal domain of EGFR via light microscopy in formalin fixed, paraffin embedded tissue following staining on a Ventana automated slide stainer. This antibody is directed against the internal domain of the human Epidermal Growth Factor Receptor (also called EGFR, ErbB1 or HER 1).
The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.",
"Language": "en",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Background Information",
"Value": "CONFIRM anti-EGFR (5B7) is a rabbit monoclonal antibody produced against a synthetic peptide from the carboxy terminal (cytoplasmic) region of EGFR. The epitope recognized by anti-EGFR (5B7) is associated with an internal domain of EGFR, and therefore EGFR staining with antibodies that recognize extracellular domains may not always correlate with CONFIRM anti-EGFR (5B7) staining.
EGFR is a member of the receptor tyrosine kinase HER family. Also known as HER 1, EGFR is structurally related to HER 2, HER 3, and HER 4. Members of this protein family are capable of forming heterodimers to mediate signal transduction. EGFR is expressed at low levels in most normal epithelial tissues, but can be overexpressed in cancers of the breast, brain, bladder, lung, gastric, head and neck, esophagus, cervix, ovary, endometrium, and particularly in squamous cell carcinomas.1
In Western blots of A431 cells, rabbit monoclonal anti-EGFR (5B7) recognizes the Mr 170 kD wild type EGFR. Specificity to EGFR was confirmed by peptide inhibition studies where antibody was incubated with a synthetic EGFR peptide. The peptide inhibited antibody binding to EGFR in tissue. The cellular staining pattern for EGFR is membrane and cytoplasmic.
1. Ciardello F, Tortora G. Epidermal growthfactor receptor (EGFR) as a target in cancer therapy: understanding the role of receptor expression and the other molecular determinants that could influence the response to anti-EGFR drugs. Eur J Cancer 39: 1348-54, 2003.",
"Language": "en",
"Country": "XG",
"Code": "Background Information"
},
{
"Name": "Product Purpose",
"Value": "This antibody is intended for in vitro diagnostic (IVD) use.
Ventana Medical Systems’ (Ventana) CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Antibody is a primary antibody designed to qualitatively detect the presence of the internal domain of EGFR via light microscopy in formalin fixed, paraffin embedded tissue following staining on a Ventana automated slide stainer. This antibody is directed against the internal domain of the human Epidermal Growth Factor Receptor (also called EGFR, ErbB1 or HER 1).
The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.",
"Language": "en",
"Country": "XG",
"Code": "Product Purpose"
}
]
}
}
]
}
