{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Control A Level 2 Bio", "DisclaimerGroup1": null, "ControlTissue": [ "" ], "BrandName": "Control A Level 2 Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "ID": "3.8.10.1.2.17", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06682227001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Solutions", "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "OWP Product Types", "NodeName": "Controls", "NodeID": "90-000-00" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio Analyzer Products", "NodeID": "02-0009" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio HT Analyzer Products", "NodeID": "02-0010" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Family", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" } ] }, "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": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "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": "Control Code: CONA2, 112, 07-1103-9", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "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.

", "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": "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 A Level 2 Bio provides target concentrations in the medium part of the measuring ranges of the following analytes: acetate, glucose, glutamate, glycerol, IgG, lactate, phosphate, total protein, potassium (ISE direct and indirect) , and sodium (ISE direct and indirect).", "Name": "Product Description" }, { "Language": "en", "Value": "For control of test accuracy on Cedex Bio and Cedex Bio HT Analyzers.", "Name": "Applications" }, { "Language": "en", "Value": "Multi-control solution.", "Name": "Positioning" }, { "Language": "en", "Value": "Clear, colorless to slightly yellowish solution.
Assigned concentration values: See pack insert", "Name": "Specification" }, { "Language": "en", "Value": "

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

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