{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Glutamate V2 Bio HT", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Glutamate V2 Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.3.4.19", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07395566001_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 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": "07395566001", "MaterialDescription": "Glutamate V2 Bio HT", "RegisteredProductName": "Glutamate V2 Bio HT", "GTIN": "07613336131770", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "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": "3.8.10.1.2.17", "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" }, { "ProductID": "3.8.10.1.2.16", "BrandName": "Control A Level 1 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 is stable for up to 8 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the reagent cassette at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "

• GLU2B: 15 - 1500 mg/L (0.1 - 10 mmol/L)
• GLU2D: 150 - 15000 mg/L (1 - 100 mmol/L),

• 1 g/L = 6.797 mmol/L
• 1 mmol/L = 147.1 mg/L

Precision
Representative performance data on Cedex Bio HT Analyzer are shown.
Results obtained in individual laboratories may differ.
Precision 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 10 days).

		Level 1	Level 2	Level 3
	Mean	0.57 mmol/L\t    (83.85 mg/L)	3. 47 mmol/L\t    (510.4 mg/L)	6.66 mmol/L\t (979.7 mg/L)
	CV in-run\t\t	0.4%	0.3%	0.5%
	CV inter-run	1.6%	2.1%	1.9%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "This product is intended for quantitative determination of glutamate in aqueous solutions using the Cedex Bio HT Instrument.", "Name": "Product Description" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Application: GLU2B (894), GLU2D (978)

Cedex Bio HT test definition:
Measuring mode\t\t\t\t   Absorbance
Abs. calculation mode\t\t  Endpoint
Reaction direction\t\t\t\t  Increase
Wavelength A/B\t\t\t\t\t  552 nm
Calc. first/last\t\t\t\t\t\t18/69 
Unit\t\t\t\t\t\t\t\t\t\t   mmol/L, mg/L
Reaction mode\t\t\t\t\t  R1-S


Calibration:
Calibrator\t\t\t\t\tCalibrator A Bio (CAL A, 07-1100-4)
Calibration mode\t   Linear regression
Calibration interval\t56 days, and if recalibration is required due to QC results

Quality control:
Control A Level 1 Bio (CONA1, 07-1101-2)
Control A Level 2 Bio (CONA2, 07-1103-9)
Control A Level 3 Bio (CONA3, 07-1104-7)
Use the recommended control material. Other suitable control material can be used in addition.
Control intervals and acceptance limits should be adapted to each laboratory's individual requirements. If values do not fall into the defined limits, corrective measures and recalibration are required
 ", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "

Vial	Content	Composition
GLU2B	Reagent cassette, 200 tests	Reagent: Glutamate oxidase, 50 U/L; peroxidase, 2 kU/L; 4-aminoantipyrine, 0.3 mmol/L; TOOS, 2 mmol/L; preservative; HEPES buffer pH 7.0.

", "Name": "Content" }, { "Language": "en", "Value": "Glutamate is a nutrient and a metabolyte in cell cultures. For optimal cell growth and product formation the glutamate concentration should be kept whithin an appropriate concentration range. For control of culture media and for monitoring in a culture process, the glutamate concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using glutamate oxidase.
Recovery: ±15%", "Name": "Specification" } ] } } ] }