{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Control D Level 1 Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Control D Level 1 Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.1.2.29", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/CB_IMAGE.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeName": "Controls", "NodeID": "90-000-00" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeName": "CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Cedex Bio Analyzer Products", "NodeID": "02-0009" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Cedex Bio HT Analyzer Products", "NodeID": "02-0010" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeName": "Manufacturing", "NodeID": "180-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeName": "NOT APPLICABLE", "NodeID": "999-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07368178001", "MaterialDescription": "Control D Level 1 Bio", "RegisteredProductName": "Control D Level 1 Bio", "GTIN": "07613336131299", "ProductCategoryText": "Controls", "OldMaterialNumber": "", "PackSizePIM360": "6 x 1 mL", "PackSizeDescPIM360": "", "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": "Life Science->RLS Custom Biotech Systems->Cedex Bio", "StructureGroupName": "Cedex Bio" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems" }, { "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" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "490", "StructureGroupPath": "Cedex", "StructureGroupName": "Cedex" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "Manufacturing", "StructureGroupName": "Manufacturing" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0008", "StructureGroupPath": "CustomBiotech->Biologics", "StructureGroupName": "Biologics" } ] }, { "ProductID": "INS_3590", "BrandName": "Cedex Bio HT Analyzer", "ProductNameAddition": "Bioprocess analyzer", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "8480", "StructureGroupPath": "Life Science->RLS Custom Biotech Systems->Cedex Bio HT", "StructureGroupName": "Cedex Bio HT" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems" }, { "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" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "490", "StructureGroupPath": "Cedex", "StructureGroupName": "Cedex" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "Manufacturing", "StructureGroupName": "Manufacturing" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0008", "StructureGroupPath": "CustomBiotech->Biologics", "StructureGroupName": "Biologics" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Open vial is stable for 1 day at +15 to +25°C.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the product at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "This product is intended for quality control by monitoring accuracy and precision of quantitative tests on the Cedex Bio and Cedex Bio HT Analyzers.
Control D Level 1 Bio provides target concentrations in the lower part of the measuring ranges of the following tests:

• Acetate (AC2B)
• Formate (FORB)
• Galactose (GALB)
• Pyruvate (PYRB)
• Sucrose (SUCB)

Use this control as described in the instructions of the respective test.", "Name": "Product Description" }, { "Language": "en", "Value": "Control Code: COND1, 307, 07-1143-8", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "For control of test accuracy on Cedex Bio and Cedex Bio HT Analyzers.", "Name": "Applications" }, { "Language": "en", "Value": "The Control D Level 1 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.

", "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.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Multi-control solution.", "Name": "Positioning" }, { "Language": "en", "Value": "Clear, colorless solution.
Assigned concentration values: See pack insert", "Name": "Specification" }, { "Language": "en", "Value": "

Vial / Bottle	Cap	Label	Content
1	colorless	Control D Level 1 Bio	6 vials, 1 mL each

", "Name": "Content" } ] } } ] }