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INTRODUCTION
The K-ASSAY Direct HDL-Cholesterol Calibrator is intended to be used for the calibration of the
K-ASSAY
Direct HDL-Cholesterol liquid chemistry assay for quantitating Direct HDL-Cholesterol
in serum samples.
For In Vitro Diagnostic Use.
SET COMPOSITION
Calibrators should be used as specified in the
K-ASSAY Direct
HDL-Cholesterol liquid chemistry assay package
insert.
KHD-C01 Direct HDL-Cholesterol Calibrator
(Large)
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4 x 1 ml
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KHD-C02 Direct HDL-Cholesterol Calibrator
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1 x 1 ml
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CALIBRATOR VALUES
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HDL-Cholesterol Value (mg/dl)
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62.0
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The values for the K-ASSAY Direct HDL-Cholesterol Calibrator are continually being revised
through ongoing quality assurance. As a result, the expected values may change from lot to lot. Please
refer to the package insert for each lot for the exact calibrator values.
The established HDL-Cholesterol value for the K-ASSAY
Direct HDL-Cholesterol Calibrator is traceable to National Institute of
Standards Standard Reference Material (1951a). The value was assigned
on the basis of ultracentrifugation and quantification of the remaining
Cholesterol. The procedures used to assign value to this calibrator
materials meet the requirements of the "HDL Cholesterol Method
Evaluation Protocol for Manufactures" of the U.S. National Reference
System for Cholesterol, CRMLN (Cholesterol Reference Method Laboratory
Network), August 1995.
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Tel: (206) 575-8068