{ "ProductData": { "ID": "INS_2111", "ProductType": "Instrument", "BrandName": "cobas z 480 analyzer", "ProductNameAddition": "", "RegulatoryDisclaimer1": "See country-specific product labeling for regulatory status.", "DisclaimerGroup1": "Country Specific Labeling", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "cobas z 480" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/INS_2111_cobas_z_480_Analyzer.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "1", "StructureSystemName": "GPCH", "NodeID": "2317", "StructureNodeStatus": "", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "10-000-00", "StructureNodeStatus": "valid", "NodeName": "Analyzer Instruments and Systems" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "110", "StructureNodeStatus": "valid", "NodeName": "cobas" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "050-00", "StructureNodeStatus": "valid", "NodeName": "Core Lab" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "010-00", "StructureNodeStatus": "valid", "NodeName": "Molecular Lab" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "100", "StructureNodeStatus": "valid", "NodeName": "Molecular" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "210-00", "StructureNodeStatus": "valid", "NodeName": "PCR/qPCR" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "300-00", "StructureNodeStatus": "valid", "NodeName": "RT-PCR/qRT-PCR" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "055", "StructureNodeStatus": "valid", "NodeName": "Laboratory developed testing" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05200881001", "MaterialDescription": "cobas z 480", "RegisteredProductName": "cobas z 480 analyzer", "GTIN": "04015630929016", "ProductCategoryText": "Instruments", "OldMaterialNumber": "", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "RMD-4800-CDIFF-001", "BrandName": "cobas^® Cdiff Test", "ProductNameAddition": "for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0032", "StructureGroupPath": "Molecular->cobas Cdiff Test - 4800", "StructureGroupName": "cobas Cdiff Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "09-00-00", "StructureGroupPath": "Colostrium difficile", "StructureGroupName": "Colostrium difficile", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "13-00-00", "StructureGroupPath": "Gastroenterology", "StructureGroupName": "Gastroenterology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "14-00-00", "StructureGroupPath": "Diarrhoeal disease", "StructureGroupName": "Diarrhoeal disease", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "18-00-00", "StructureGroupPath": "Gastrointestinal infections", "StructureGroupName": "Gastrointestinal infections", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "21-00-00", "StructureGroupPath": "Inflammation", "StructureGroupName": "Inflammation", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "090", "StructureGroupPath": "Microbiology", "StructureGroupName": "Microbiology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "19-00-00", "StructureGroupPath": "Healthcare-associated infections", "StructureGroupName": "Healthcare-associated infections", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "19-00-00", "StructureGroupPath": "Qualitative Detection", "StructureGroupName": "Qualitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "115", "StructureGroupPath": "Antimicrobial Stewardship", "StructureGroupName": "Antimicrobial Stewardship", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-CMV-001", "BrandName": "cobas^® CMV Test", "ProductNameAddition": "Quantitative nucleic acid test for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0034", "StructureGroupPath": "Molecular->cobas CMV Test - 4800", "StructureGroupName": "cobas CMV Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "11-00-00", "StructureGroupPath": "Cytomegalovirus (CMV)", "StructureGroupName": "Cytomegalovirus (CMV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "43-00-00", "StructureGroupPath": "Transplant-transmitted infections", "StructureGroupName": "Transplant-transmitted infections", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "34-00-00", "StructureGroupPath": "Quantitative Detection", "StructureGroupName": "Quantitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "113", "StructureGroupPath": "Transplant", "StructureGroupName": "Transplant", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-EGFRV2-003", "BrandName": "cobas^® EGFR Mutation Test v2", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0040", "StructureGroupPath": "Molecular->cobas EGFR Mutation Test - 4800", "StructureGroupName": "cobas EGFR Mutation Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "32-00-00", "StructureGroupPath": "Mutation Detection", "StructureGroupName": "Mutation Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "23-00-00", "StructureGroupPath": "Lung cancer", "StructureGroupName": "Lung cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-F2F5-001", "BrandName": "cobas^® Factor II and Factor V Test", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0041", "StructureGroupPath": "Molecular->cobas Factor II and Factor V Test - 4800", "StructureGroupName": "cobas Factor II and Factor V Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "40-00-00", "StructureGroupPath": "Thrombophilia", "StructureGroupName": "Thrombophilia", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "15-00-00", "StructureGroupPath": "Hematology", "StructureGroupName": "Hematology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "09-00-00", "StructureGroupPath": "Genotyping", "StructureGroupName": "Genotyping", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-HBV-001", "BrandName": "cobas^® HBV", "ProductNameAddition": "Quantitative nucleic acid test for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0042", "StructureGroupPath": "Molecular->cobas HBV Test - 4800", "StructureGroupName": "cobas HBV Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "18-00-00", "StructureGroupPath": "Hepatitis B (HBV)", "StructureGroupName": "Hepatitis B (HBV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "16-00-00", "StructureGroupPath": "Hepatology", "StructureGroupName": "Hepatology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "22-00-00", "StructureGroupPath": "Liver cancer", "StructureGroupName": "Liver cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "45-00-00", "StructureGroupPath": "Viral hepatitis", "StructureGroupName": "Viral hepatitis", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "34-00-00", "StructureGroupPath": "Quantitative Detection", "StructureGroupName": "Quantitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "100", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-HCV-001", "BrandName": "cobas^® HCV", "ProductNameAddition": "Quantitative nucleic acid test for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0700", "StructureGroupPath": "Molecular->cobas HCV Test - 4800", "StructureGroupName": "cobas HCV Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "19-00-00", "StructureGroupPath": "Hepatitis C (HCV)", "StructureGroupName": "Hepatitis C (HCV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "16-00-00", "StructureGroupPath": "Hepatology", "StructureGroupName": "Hepatology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "45-00-00", "StructureGroupPath": "Viral hepatitis", "StructureGroupName": "Viral hepatitis", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "34-00-00", "StructureGroupPath": "Quantitative Detection", "StructureGroupName": "Quantitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "100", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-HCVGT-001", "BrandName": "cobas^® HCV GT", "ProductNameAddition": "HCV genotyping test for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0044", "StructureGroupPath": "Molecular->cobas HCV GT Test - 4800", "StructureGroupName": "cobas HCV GT Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "19-00-00", "StructureGroupPath": "Hepatitis C (HCV)", "StructureGroupName": "Hepatitis C (HCV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "16-00-00", "StructureGroupPath": "Hepatology", "StructureGroupName": "Hepatology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "45-00-00", "StructureGroupPath": "Viral hepatitis", "StructureGroupName": "Viral hepatitis", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "09-00-00", "StructureGroupPath": "Genotyping", "StructureGroupName": "Genotyping", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "100", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-HPV-001", "BrandName": "cobas^® 4800 HPV Amplification/Detection Kit", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0701", "StructureGroupPath": "Molecular->cobas HPV Test - 4800", "StructureGroupName": "cobas HPV Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "24-00-00", "StructureGroupPath": "Human papillomavirus (HPV)", "StructureGroupName": "Human papillomavirus (HPV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "14-00-00", "StructureGroupPath": "Gynecology", "StructureGroupName": "Gynecology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "09-00-00", "StructureGroupPath": "Cervical cancer", "StructureGroupName": "Cervical cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "19-00-00", "StructureGroupPath": "Qualitative Detection", "StructureGroupName": "Qualitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "114", "StructureGroupPath": "Sexual Health", "StructureGroupName": "Sexual Health", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-HSV-001", "BrandName": "cobas^® HSV 1 and 2 Test", "ProductNameAddition": "for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0048", "StructureGroupPath": "Molecular->cobas HSV 1 and 2 Test - 4800", "StructureGroupName": "cobas HSV 1 and 2 Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "22-00-00", "StructureGroupPath": "Herpes simplex virus (HSV)", "StructureGroupName": "Herpes simplex virus (HSV)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "19-00-00", "StructureGroupPath": "Qualitative Detection", "StructureGroupName": "Qualitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "37-00-00", "StructureGroupPath": "Sexually-transmitted infections (STIs)", "StructureGroupName": "Sexually-transmitted infections (STIs)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "114", "StructureGroupPath": "Sexual Health", "StructureGroupName": "Sexual Health", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-KRAS-001", "BrandName": "cobas^® KRAS Mutation Test", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0052", "StructureGroupPath": "Molecular->cobas KRAS Mutation Test - 4800", "StructureGroupName": "cobas KRAS Mutation Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "13-00-00", "StructureGroupPath": "Gastroenterology", "StructureGroupName": "Gastroenterology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "11-00-00", "StructureGroupPath": "Colorectal cancer", "StructureGroupName": "Colorectal cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "32-00-00", "StructureGroupPath": "Mutation Detection", "StructureGroupName": "Mutation Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-LSR-001", "BrandName": "BRAF/NRAS Mutation Test (LSR)", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "06-0062", "StructureGroupPath": "LifeScience->BRAF/NRAS Mutation Test LSR - 4800", "StructureGroupName": "BRAF/NRAS Mutation Test LSR - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "38-00-00", "StructureGroupPath": "Skin cancer", "StructureGroupName": "Skin cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "170-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "999", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-LSR-002", "BrandName": "KRAS Mutation Test v2 (LSR)", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "06-0029", "StructureGroupPath": "LifeScience->KRAS Mutation Test v2 LSR - 4800", "StructureGroupName": "KRAS Mutation Test v2 LSR - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "13-00-00", "StructureGroupPath": "Gastroenterology", "StructureGroupName": "Gastroenterology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "11-00-00", "StructureGroupPath": "Colorectal cancer", "StructureGroupName": "Colorectal cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "170-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "999", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-MRSASA-001", "BrandName": "cobas^® MRSA/SA Test", "ProductNameAddition": "for use on the cobas^® 4800 System", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0056", "StructureGroupPath": "Molecular->cobas MRSA/SA Test - 4800", "StructureGroupName": "cobas MRSA/SA Test - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "29-00-00", "StructureGroupPath": "Methicillin-resistant Staphylococcus aureus (MRSA)", "StructureGroupName": "Methicillin-resistant Staphylococcus aureus (MRSA)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "17-00-00", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "04-00-00", "StructureGroupPath": "Antimicrobial resistance", "StructureGroupName": "Antimicrobial resistance", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "090", "StructureGroupPath": "Microbiology", "StructureGroupName": "Microbiology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "19-00-00", "StructureGroupPath": "Healthcare-associated infections", "StructureGroupName": "Healthcare-associated infections", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "19-00-00", "StructureGroupPath": "Qualitative Detection", "StructureGroupName": "Qualitative Detection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "115", "StructureGroupPath": "Antimicrobial Stewardship", "StructureGroupName": "Antimicrobial Stewardship", "StructureNodeStatus": "valid" } ] }, { "ProductID": "RMD-4800-PIK3CA-001", "BrandName": "cobas^® PIK3CA Mutation Test", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "06-0068", "StructureGroupPath": "LifeScience->cobas PIK3CA Mutation Test RUO - 4800", "StructureGroupName": "cobas PIK3CA Mutation Test RUO - 4800", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "20-000-00", "StructureGroupPath": "Assays Reagents and Strips", "StructureGroupName": "Assays Reagents and Strips", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "210-00", "StructureGroupPath": "PCR/qPCR", "StructureGroupName": "PCR/qPCR", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "14-00-00", "StructureGroupPath": "Gynecology", "StructureGroupName": "Gynecology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "19-00-00", "StructureGroupPath": "Oncology", "StructureGroupName": "Oncology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "08-00-00", "StructureGroupPath": "Breast cancer", "StructureGroupName": "Breast cancer", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "170-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "117", "StructureGroupPath": "Genomics and Oncology", "StructureGroupName": "Genomics and Oncology", "StructureNodeStatus": "valid" } ] }, { "ProductID": "3.5.8.1.5.4", "BrandName": "LightCycler^® 480 QC Kit", "ProductNameAddition": "", "ReferenceType": "Control", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "06-0017", "StructureGroupPath": "LifeScience->LightCycler 480 Kits", "StructureGroupName": "LightCycler 480 Kits", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "90-000-00", "StructureGroupPath": "Controls", "StructureGroupName": "Controls", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "230", "StructureGroupPath": "LightCycler", "StructureGroupName": "LightCycler", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "150-00", "StructureGroupPath": "Research Lab", "StructureGroupName": "Research Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" } ] }, { "ProductID": "RMD-4800-019", "BrandName": "cobas^® Plasma Separation Card", "ProductNameAddition": "", "ReferenceType": "Auxilliary", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "03-0061", "StructureGroupPath": "Molecular->cobas Plasma Separation Card", "StructureGroupName": "cobas Plasma Separation Card", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "95-000-00", "StructureGroupPath": "Auxiliaries", "StructureGroupName": "Auxiliaries", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "110", "StructureGroupPath": "cobas", "StructureGroupName": "cobas", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "010-00", "StructureGroupPath": "Molecular Lab", "StructureGroupName": "Molecular Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "100", "StructureGroupPath": "Molecular", "StructureGroupName": "Molecular", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "240-00", "StructureGroupPath": "Sample Collection", "StructureGroupName": "Sample Collection", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as a diagnostics system providing real time PCR amplification and detection for human samples within the system.

The cobas x 480 instrument and cobas z 480 analyzer are to be used by trained laboratory professionals.

Intended Use statements for the assays on the cobas^® 4800 System are located within the Instructions for Use for respective tests run on the system.", "Language": "en", "Country": "XG", "Code": "Intended Use" } ] } } ] }