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9-14 Regulatory Information
Calibration
Results
Limitations of the Procedure
Expected Values
Performance Characteristics
Available from the National Committee for Clinical Laboratory Standards, 940
West Valley Road, Suite 1400, Wayne, PA, 19087-1898
System Method Information: Intended Use
This topic contains a brief statement of intended use for the assay as an
in vitro
diagnostic procedure for quantitating analytes in human whole blood.
System Method Information: Principles of the Procedure
This topic provides a physical, chemical, and/or biological explanation of the
assay and a brief description of the reactions, where applicable.
System Method Information: Reagents
These topics describe the reagents required to perform the assay including
reagent packaging information, product descriptions, materials required but not
provided, and reagent preparation instructions.
The following briefly explains the significance of signal words used throughout
these topics:
CAUTION!
Indicates a hazard that could cause illness, burns, skin reactions, and so on. This
hazard is assigned to substances such as diluted acids, mild caustics, minor skin
irritants, or combustible materials.
ATTENTION
Indicates that a specific risk exists to the user or performance.
NOTE
Indicates additional information that is useful for the proper operation of the
system.
NOTE:
The customer must maintain a constant awareness of the hazards and
warnings associated with all reagents. Where necessary, appropriate safety
equipment should be used (e.g., eye protection, gloves, lab coats). Users should
follow the handling and safety precautions specified in the Material Safety Data
Sheets available from Siemens.
Reagent and Calibrator Preparation
Reagents and calibrators are ready-to-use and require no preparation.