{ "ProductData": { "ID": "3.8.10.1.2.33", "ProductType": "Others", "BrandName": "Control OD Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "RegulatoryDisclaimer1": "For use in quality control/manufacturing process only.", "DisclaimerGroup1": "", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Control OD Level 2 Bio" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07766645001_im_en.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "90-000-00", "StructureNodeStatus": "valid", "NodeName": "Controls" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeID": "01-01-01-07-00", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech and LifeScience" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0009", "StructureNodeStatus": "valid", "NodeName": "Cedex Bio Analyzer Products" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "02-0010", "StructureNodeStatus": "valid", "NodeName": "Cedex Bio HT Analyzer Products" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "490", "StructureNodeStatus": "valid", "NodeName": "Cedex" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "520", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "180-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "999-00", "StructureNodeStatus": "invalid", "NodeName": "" }, { "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": "07766645001", "MaterialDescription": "Control OD Level 2 Bio", "RegisteredProductName": "Control OD Level 2 Bio", "GTIN": "07613336102633", "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" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing", "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" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing", "StructureNodeStatus": "valid" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Storage Conditions (Product)", "Value": "Store the product at +2 to +8°C.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Protocols - Help Corner", "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.", "Language": "en", "Country": "XG", "Code": "Protocols - Help Corner" }, { "Name": "Protocols", "Value": "The Control OD Level 2 Bio is ready to use.
  1. Mix thoroughly with a vortex mixer before use. 
    Avoid the formation of foam. 
Use this control as described in the Instructions for Use of the respective assay.
For information about working with barcodes, refer to the respective Operator's Manual. When the barcode information is scanned into the Bio HT Analyzer Software, the 3s value will automatically be used for the Permissible Deviation in the Accuracy Mode.
", "Language": "en", "Country": "XG", "Code": "Protocols" }, { "Name": "Product Description", "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. Control OD Level 2 Bio provides an optical densitiy at 583 nm in the medium part of the measuring range of the OD test.Use this control as described in the instructions of the respective test.", "Language": "en", "Country": "XG", "Code": "Product Description" }, { "Name": "CB - Order Information", "Value": "Unit of measure is \"piece\".", "Language": "en", "Country": "XG", "Code": "CB - Order Information" }, { "Name": "Applications", "Value": "For control of the accuracy of the OD test on Cedex Bio and Cedex Bio HT Analyzers.", "Language": "en", "Country": "XG", "Code": "Applications" }, { "Name": "Positioning", "Value": "Optical density control suspension.", "Language": "en", "Country": "XG", "Code": "Positioning" }, { "Name": "Specification", "Value": "White, turbid suspension.
Assigned concentration values: See pack insert", "Language": "en", "Country": "XG", "Code": "Specification" }, { "Name": "Content", "Value": "
Vial / BottleCapLabelContent
1colorlessControl OD Level 2 Bio6 vials,
1 mL each
", "Language": "en", "Country": "XG", "Code": "Content" } ] } } ] }

Control OD Level 2 Bio

for Cedex Bio and Cedex Bio HT Analyzers

cedex-control-od-level-2-bio