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quality control by monitoring accuracy and precision of quantitative assays using Cedex Bio and Bio HT Analyzers*:
  • Acetate (AC2B, AC2D)
  • Ala-Gln (AQB, AQD)
  • Arabinose (ARAB, ARAD)
  • Formate (FORB, FORD)
  • Galactose (GAL2B, GAL2D)
  • Nitrate (NO3B, NO3D)
  • Pyruvate (PYRB, PYRD)
  • Sucrose (SUCB, SUCD)
", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" }, { "Language": "en", "Value": "For control of test accuracy on Cedex Bio and Cedex Bio HT Analyzers.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "The Control D Level 3 Bio is ready to use.
  1. Mix carefully before use.
    Avoid the formation of foam.
  2. Remove any air bubbles by microcentrifugation for 10 to 20 seconds.
Use this control as described in the Instructions for 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.
", "Country": "XG", "Code": "Protocols", "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.", "Country": "XG", "Code": "Protocols - Help Corner", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Multi-control solution.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "Clear, colorless solution.
Assigned concentration values: See pack insert", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "
Vial / BottleCapLabelContent
1purpleControl D Level 3 Bio6 vials,
1 mL each
", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "
Precautions
  • Handle all samples as if potentially infectious, using safe laboratory procedures. As the sensitivity and titer of potential pathogens in the sample material can vary, the operator must optimize pathogen inactivation and follow the appropriate measures according to local safety regulations.
  • Do not eat, drink, or smoke in the laboratory work area.
  • Do not pipette by mouth.
  • Wear protective disposable gloves, laboratory coats, and eye protection, when handling samples and kit reagents.
  • Wash hands thoroughly after handling samples and reagents.
Waste handling
  • Discard unused reagents and waste in accordance with country, federal, state, and local regulations.
  • Safety Data Sheets (SDS) are available online at documentation.roche.com, or upon request from the local Roche office.
", "Country": "XG", "Code": "Safety Information", "Name": "Safety Information" } ] } } ] }

Control D Level 3 Bio

for Cedex Bio and Cedex Bio HT Analyzers

control-d-level-3-bio