{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Lactate Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Lactate Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.2", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06343759001_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": "Assays Reagents and Strips", "NodeID": "20-000-00" }, { "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": "OWP_Family", "StructureSystemName": "Family", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "06343759001", "MaterialDescription": "Lactate Cedex Bio", "RegisteredProductName": "Lactate Bio", "GTIN": "07613336133460", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\". Will be supplied as \"Lactate Cedex Bio\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.15", "BrandName": "Calibrator A Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.16", "BrandName": "Control A Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.17", "BrandName": "Control A Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.18", "BrandName": "Control A Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Keep at +2 to +15°C for on-board use.
After first use on the instrument, the reagent cassette is stable for up to 4 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "

• Cedex Bio Analyzer*, including accessories and disposables
• Standard laboratory equipment

• Calibrator A Bio*
• Control A Level 1 Bio*
• Control A Level 2 Bio*
• Control A Level 3 Bio*

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Kit for determination of lactate.", "Name": "Product Description" }, { "Language": "en", "Value": "Measuring Range
\nLactate concentration can be determined in following ranges:\n

\n\t
• LAC2B: 4 - 1400 mg/L (0.0444 - 15.5 mmol/L)
\n\t
• LAC2D: 40 – 14 000 mg/L (0.444 - 155 mmol/L), up to 14 0000 mg/L (1550 mmol/L) with postdilution
\n

\n
\nConversion Factors
\nConversion factors for lactate concentration:\n

\n\t
• 1 mmol/L = 90.09 mg/L
\n\t
• 1 g/L = 11.10 mmol/L
\n

\n
\nTraceability
\nThis method has been standardized against primary standard material.
\n
\nPrecision
\nRepresentative performance data on Cedex Bio analyzers are shown. Results obtained in individual laboratories may differ.
\nPrecision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 30 days).
\n \n\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n

	Level 1	Level 2	Level 3
Mean	1.71 mmol/L \n\t\t\t(154 mg/L)	3.27 mmol/L \n\t\t\t(295 mg/L)	8.80 mmol/L \n\t\t\t(613 mg/L)
CV in-run	0.9 %	0.3 %	0.4 %
CV inter-run	0.9 %	0.2 %	0.2 %

\n", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 LAC2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): Hydrogen donor, 1.75 mmol/L; ascorbate oxidase (cucumber), 501 μkat/L; buffer; preservative.
2 LAC2B SR	black	4 vials, 50 tests each	Start Reagent (SR): 4-aminoantipyrine, 5 mmol/L; lactate oxidase (microbial), 251 μkat/L; peroxidase (horseradish), 401 μkat/L; buffer; preservative.

", "Name": "Content" }, { "Language": "en", "Value": "Lactate is an important metabolyte in cell cultures, and accumulation of lactate can suppress cell growth and product formation. For monitoring in a culture process, lactate can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Additional information about the calibration of the LAC2D protocol (dilution protocol)
Both the LAC2B and LAC2D protocols are calibrated via a 2-point linear regression curve. However, in the case of the LAC2D protocol, the calibrator is first diluted 1:10 to create the first standard. The second standard is water. In general, when the system performs an automatic dilution step to create a standard, the system only requires information about the lot-specific concentration of the analyte, provided in the Instructions for Use for the relevant calibrator. Therefore, the system will not ask for information about a second standard in the case of the LAC2 protocol.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using lactate oxidase.
Recovery: ±10%", "Name": "Specification" } ] } } ] }