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{
"ProductData": {
"RelatedLinks": "",
"RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.",
"RegulatoryDisclaimer2": "",
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""
],
"ProductType": "Others",
"DisclaimerGroup2": null,
"ProductNameGlobal": "Control D Level 1 Bio",
"DisclaimerGroup1": "Non-IVD",
"ControlTissue": [
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],
"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": [
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"Clone": ""
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"StructureSystemIdentifier": "OWP_Product_Solutions",
"StructureSystemName": "OWP Product Solutions",
"NodeName": "CustomBiotech",
"NodeID": "520"
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{
"StructureSystemIdentifier": "OWP_Product_Types",
"StructureSystemName": "OWP Product Types",
"NodeName": "Controls",
"NodeID": "90-000-00"
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"NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience",
"NodeID": "01-01-01-07-00"
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{
"StructureSystemIdentifier": "Product_Grouping",
"StructureSystemName": "Product Grouping",
"NodeName": "CustomBiotech->Cedex Bio Analyzer Products",
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{
"StructureSystemIdentifier": "Product_Grouping",
"StructureSystemName": "Product Grouping",
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"Product2Materials": {
"P2MaterialReferences": [
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"MaterialNum": "07368178001",
"MaterialDescription": "Control D Level 1 Bio",
"RegisteredProductName": "Control D Level 1 Bio",
"GTIN": "07613336131299",
"ProductCategoryText": "Controls",
"OldMaterialNumber": "",
"PackSizePIM360": "6 x 1 mL",
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"MaterialAnnotation": "CustomBiotech product. Please contact your local representative.",
"ReadyForUse": "true",
"OrderInformation": "Unit of measure is \"piece\"."
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"ProductSpec": [
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"Chapters": [
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"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)"
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{
"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"
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{
"Language": "en",
"Value": "Control Code: COND1, 307, 07-1143-8",
"Name": "Background Information - Help Corner"
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{
"Language": "en",
"Value": "Unit of measure is \"piece\".",
"Name": "CB - Order Information"
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{
"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.
Mix carefully before use.
Avoid the formation of foam.
Remove any air bubbles by microcentrifugation for 10 to 20 seconds.
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 for the standard deviation will automatically be used for the Permissible Deviation in the Accuracy Mode.
",
"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"
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"Value": "Multi-control solution.",
"Name": "Positioning"
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{
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"Value": "Clear, colorless solution. Assigned concentration values: See pack insert",
"Name": "Specification"
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{
"Language": "en",
"Value": "