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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.",
"Language": "en",
"Country": "XG",
"Code": "Protocols - Help Corner"
},
{
"Name": "Protocols",
"Value": "
After thawing, mix Control B level 1 Bio thoroughly for 10 to 20 seconds on a vortex mixer.
Spin down for 10 to 20 seconds using a microcentrifuge. – The control is ready for use.
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 will automatically be used for the Permissible Deviation in the Accuracy Mode.
",
"Language": "en",
"Country": "XG",
"Code": "Protocols"
},
{
"Name": "Background Information - Help Corner",
"Value": "Control code: CONB1, 401, 07-1106-3",
"Language": "en",
"Country": "XG",
"Code": "Background Information - Help Corner"
},
{
"Name": "CB - Order Information",
"Value": "Unit of measure is \"piece\".",
"Language": "en",
"Country": "XG",
"Code": "CB - Order Information"
},
{
"Name": "Positioning",
"Value": "Multi-control solution.",
"Language": "en",
"Country": "XG",
"Code": "Positioning"
},
{
"Name": "Applications",
"Value": "For control of test accuracy on Cedex Bio and Cedex Bio HT Analyzers.",
"Language": "en",
"Country": "XG",
"Code": "Applications"
},
{
"Name": "Specification",
"Value": "Clear, colorless solution. Assigned concentration values: See pack insert",
"Language": "en",
"Country": "XG",
"Code": "Specification"
},
{
"Name": "Content",
"Value": "↵
Vial / Bottle
Cap
Label
Content
1
colorless
Control B Level 1 Bio
6 vials, 0.5 mL each
",
"Language": "en",
"Country": "XG",
"Code": "Content"
},
{
"Name": "Intended Use",
"Value": "This product is intended for quality control by monitoring accuracy and precision of quantitative assays using Cedex Bio and Cedex Bio HT Analyzers*: