{ "ProductData": { "ID": "3.8.10.1.2.17", "ProductType": "Others", "BrandName": "Control A Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "RegulatoryDisclaimer1": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "DisclaimerGroup1": "", "RegulatoryDisclaimer2": "", "DisclaimerGroup2": null, "RegulatoryDisclaimer3": "", "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Control A Level 2 Bio" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06682227001_im_en.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Controls", "NodeID": "90-000-00" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "Cedex Bio Analyzer Products", "NodeID": "02-0009" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "Cedex Bio HT Analyzer Products", "NodeID": "02-0010" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "valid", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "180-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "06682227001", "MaterialDescription": "Control A Level 2 Bio", "RegisteredProductName": "Control A Level 2 Bio", "GTIN": "07613336131213", "ProductCategoryText": "Controls", "OldMaterialNumber": "", "PackSizePIM360": "6 x 1 mL", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_3590", "BrandName": "Cedex Bio HT Analyzer", "ProductNameAddition": "Bioprocess analyzer", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "8480", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Organization", "NameofStructureSystem": "Organization", "StructureNodeID": "01-01-01-07-00", "StructureGroupPath": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureGroupName": "CustomBiotech and LifeScience", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "490", "StructureGroupPath": "Cedex", "StructureGroupName": "Cedex", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "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": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0008", "StructureGroupPath": "CustomBiotech->Biologics", "StructureGroupName": "Biologics", "StructureNodeStatus": "valid" } ] }, { "ProductID": "INS_2895", "BrandName": "Cedex Bio Analyzer", "ProductNameAddition": "Bioprocess analyzer", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "7083", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Organization", "NameofStructureSystem": "Organization", "StructureNodeID": "01-01-01-07-00", "StructureGroupPath": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureGroupName": "CustomBiotech and LifeScience", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "490", "StructureGroupPath": "Cedex", "StructureGroupName": "Cedex", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech", "StructureNodeStatus": "valid" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "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": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "invalid" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0008", "StructureGroupPath": "CustomBiotech->Biologics", "StructureGroupName": "Biologics", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The Control A Level 2 is ready for use.

1. Mix carefully before use.
   Avoid the formation of foam.
2. Remove any air bubbles by microcentrifugation for 10 to 20 seconds.

", "Country": "XG", "Code": "Protocols", "Name": "Protocols" }, { "Language": "en", "Value": "Rule 1 settings for Quality Control (QC) on the Cedex Bio Analyzer

Roche recommends starting with a three-fold of the value of the standard deviation, 1s, defined for each analyte in the relevant lot-specific Instructions for Use for Controls. The value is defined in Utilities->Configuration->QC->Rule 1->3s. However, each lab must determine the appropriate values according to local preferences or requirements.", "Country": "XG", "Code": "Protocols - Help Corner", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "For control of test accuracy on Cedex Bio and Cedex Bio HT Analyzers.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Multi-control solution.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "Clear, colorless to slightly yellowish solution.
Assigned concentration values: See pack insert", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "

Vial / Bottle	Cap	Label	Content
1	yellow	Control A Level 2 Bio	6 vials,  1 mL each

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "This product is intended for quality control by monitoring accuracy and precision of quantitative assays using Cedex Bio and Cedex Bio HT Analyzers*:

• Glucose (GLC2B, GLC2D, GLC3B, GLC3D)
• Glutamate (GLU2B, GLU2D)
• Glycerol (GLYB, GLYD)
• IgG (IGGHB, IGGHD)
• Lactate (LAC2B, LAC2D)
• Phosphate (PHO2B, PHO2D)
• Sucrose (SUCB, SUCD) – only for correction of glucose background
• Total Protein (TP2B)

", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" } ] } } ] }