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"StructureGroupPath": "Women's Health", "StructureGroupName": "Women's Health", "StructureNodeStatus": "valid" } ] }, { "ProductID": "CPS_000475", "BrandName": "Elecsys^® Androstenedione", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0876", "StructureGroupPath": "CPS->Elecsys Androstenedione", "StructureGroupName": "Elecsys Androstenedione", "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": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "14-00-00", "StructureGroupPath": "Gynecology", "StructureGroupName": "Gynecology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "022", "StructureGroupPath": "Immunochemistry", "StructureGroupName": "Immunochemistry", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "20-00-00", "StructureGroupPath": "Infertility", "StructureGroupName": "Infertility", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "98", "StructureGroupPath": "Fertility", "StructureGroupName": "Fertility", "StructureNodeStatus": "valid" } ] }, { "ProductID": "CPS_000616", "BrandName": "Elecsys^® Anti-SARS-CoV-2 S", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0900", "StructureGroupPath": "CPS->Elecsys Anti-SARS-CoV-2 S", "StructureGroupName": "Elecsys Anti-SARS-CoV-2 S", "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": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "10-00-00", "StructureGroupPath": "Coronavirus (COVID)", "StructureGroupName": "Coronavirus (COVID)", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": 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"IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0901", "StructureGroupPath": "CPS->Elecsys HBsAg Auto Confirm", "StructureGroupName": "Elecsys HBsAg Auto Confirm", "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": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "18-00-00", "StructureGroupPath": "Hepatitis B (HBV)", "StructureGroupName": "Hepatitis B (HBV)", "StructureNodeStatus": "valid" }, { 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"NameofStructureSystem": "Health Topics", "StructureNodeID": "20-00-00", "StructureGroupPath": "Pulmonology", "StructureGroupName": "Pulmonology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "022", "StructureGroupPath": "Immunochemistry", "StructureGroupName": "Immunochemistry", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "100", "StructureGroupPath": "Infectious Diseases", "StructureGroupName": "Infectious Diseases", "StructureNodeStatus": "valid" } ] }, { "ProductID": "PID00000019", "BrandName": "Elecsys^® FT4 IV", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "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": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0245", "StructureGroupPath": "CPS->Elecsys FT4", "StructureGroupName": "Elecsys FT4", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "12-00-00", "StructureGroupPath": "Endocrinology", "StructureGroupName": "Endocrinology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "27-00-00", "StructureGroupPath": "Metabolic disease", "StructureGroupName": "Metabolic disease", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "022", "StructureGroupPath": "Immunochemistry", "StructureGroupName": "Immunochemistry", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" } ] }, { "ProductID": "CPS_000429", "BrandName": "Elecsys^® ACTH", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0200", "StructureGroupPath": "CPS->Elecsys ACTH", "StructureGroupName": "Elecsys ACTH", "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": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "12-00-00", "StructureGroupPath": "Endocrinology", "StructureGroupName": "Endocrinology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "022", "StructureGroupPath": "Immunochemistry", "StructureGroupName": "Immunochemistry", "StructureNodeStatus": "valid" }, { "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": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "97", "StructureGroupPath": "Endocrinology", "StructureGroupName": "Endocrinology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "310-00", "StructureGroupPath": "Heterogeneous and Homogeneous Immunoassays", "StructureGroupName": "Heterogeneous and Homogeneous Immunoassays", "StructureNodeStatus": "valid" } ] }, { "ProductID": "PID00000510", "BrandName": "Elecsys^® Cortisol III", "ProductNameAddition": "", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "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": "150", "StructureGroupPath": "Elecsys", "StructureGroupName": "Elecsys", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "022", "StructureGroupPath": "Immunochemistry", "StructureGroupName": "Immunochemistry", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "01-0230", "StructureGroupPath": "CPS->Elecsys Cortisol", "StructureGroupName": "Elecsys Cortisol", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "12-00-00", "StructureGroupPath": "Endocrinology", "StructureGroupName": "Endocrinology", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Indications", "NameofStructureSystem": "Indications", "StructureNodeID": "97", "StructureGroupPath": "Endocrinology", "StructureGroupName": "Endocrinology", "StructureNodeStatus": "valid" } ] } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "cobas^® pure integrated solutions is an automated analyzer, intended for running qualitative and quantitative clinical chemistry and immunochemistry assays as well as ion selective measurements.

Supporting information
It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic devices.

The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, supernatant, oral fluid, hemolysate, amniotic fluid, processed stool and plasma that are used for detecting and/or measuring analytes covered by the specific assays.

The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).", "Language": "en", "Country": "XR", "Code": "Intended Use" } ] } } ] }