{ "ProductData": { "ID": "3.8.10.1.2.27", "ProductType": "Others", "BrandName": "Control C Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "RegulatoryDisclaimer1": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "DisclaimerGroup1": "", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Control C Level 3 Bio" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07020902001_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": "07020902001", "MaterialDescription": "Control C Level 3 Bio", "RegisteredProductName": "Control C Level 3 Bio", "GTIN": "07613336131282", "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_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" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0133", "StructureGroupPath": "CustomBiotech->Cell and Gene Therapy", "StructureGroupName": "Cell and Gene Therapy", "StructureNodeStatus": "valid" } ] }, { "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" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0133", "StructureGroupPath": "CustomBiotech->Cell and Gene Therapy", "StructureGroupName": "Cell and Gene Therapy", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Open vial is stable for 1 day at +15 to +25°C.", "Country": "XG", "Code": "Storage Conditions (Working Solution)", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The Control C Level 3 Bio is ready to 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": "This product is intended for quality control by monitoring accuracy and precision of the quantitative tests on the Cedex Bio and Cedex Bio HT Analyzers.
Use this control as described in the instructions of the respective test.
Control C Level 3 Bio provides target concentrations in the upper part of the measuring ranges of the following analytes: calcium, iron, and magnesium.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "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": "Control code 503, CONC3", "Country": "XG", "Code": "Background Information - Help Corner", "Name": "Background Information - 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 solution.
Assigned concentration values: See pack insert", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "

Vial / Bottle	Cap	Label	Content
1	purple	Control C Level 3 Bio	6 vials, 1 mL each

", "Country": "XG", "Code": "Content", "Name": "Content" } ] } } ] }