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  • Standard Human Plasma - Thrombin Reagent

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    TRITEST TRITEST
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    This document certifies the traceability and assigned values of a standard human plasma product for fibrinogen concentration. The values were assigned using nephelometry and turbidimetry against a WHO reference material. The uncertainty is 2.7% according to ISO 17511. The traceability chart shows the standard plasma was first calibrated against the WHO reference, then a master lot was defined and used to calibrate new production lots, whose assigned values customers can use.

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    Standard Human Plasma_Thrombin Reagent

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    This document certifies the traceability and assigned values of a standard human plasma product for fibrinogen concentration. The values were assigned using nephelometry and turbidimetry against a WHO reference material. The uncertainty is 2.7% according to ISO 17511. The traceability chart shows the standard plasma was first calibrated against the WHO reference, then a master lot was defined and used to calibrate new production lots, whose assigned values customers can use.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    370 views2 pages

    Standard Human Plasma - Thrombin Reagent

    Uploaded by

    TRITEST TRITEST
    This document certifies the traceability and assigned values of a standard human plasma product for fibrinogen concentration. The values were assigned using nephelometry and turbidimetry against a WHO reference material. The uncertainty is 2.7% according to ISO 17511. The traceability chart shows the standard plasma was first calibrated against the WHO reference, then a master lot was defined and used to calibrate new production lots, whose assigned values customers can use.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 2

    Siemens Healthcare Diagnostics Products GmbH

    P. O. Box 1149
    35001 Marburg, Germany
    diagnostics.siemens.com

    Certificate of Traceability
    Assigned Values

    This is to certify the traceability of the assigned values of the product listed below to a reference material.

    The uncertainty of the assigned value for this product was calculated according to the ISO norm 17511 by using
    a coverage factor of two. Expressing the uncertainty by a coefficient of variation can be done by dividing the
    given uncertainty by two.

    Product Standard Human Plasma

    Product Code ORKL

    Parameter Fibrinogen (with Dade Thrombin)

    Unit g/L

    Device for usage of assigned value all

    Reference material WHO 09/264

    Measuring method used for value assignment Nephelometry, Turbidimetry

    Uncertainty of assigned values [%] 2.7

    This document was produced by means of an electronic system, therefore without signature

    Name of document: D-00064 Effective date: 2013-06-26 Page 1 of 2


    Siemens Healthcare Diagnostics Products GmbH
    P. O. Box 1149
    35001 Marburg, Germany
    diagnostics.siemens.com

    Traceability Chart
    This is to certify the traceability chain of the assigned values of the product listed below to a reference material.

    Product Standard Human Plasma

    Product Code ORKL

    Parameter Fibrinogen (with Dade Thrombin)

    Unit g/L

    Materials & Procedures Section1)

    a
    International Standard WHO 09/264
    ⎯⎯⎯⎯→
    Primary Calibration of Standard
    Human Plasma Master-Lot with b
    reference material
    ←⎯⎯⎯⎯
    Master Calibrator Standard Human
    b
    Plasma Lot defined
    ⎯⎯⎯⎯→
    Secondary Calibration of new
    b
    Production Lot vs. Master-Lot
    ←⎯⎯⎯⎯
    Standard Human Plasma-Lot
    b
    calibrated; value assigned
    ⎯⎯⎯⎯→
    Customer: use of assigned value on
    c
    instrument

    -
    1)
    a = External material / procedure
    b = Company internal
    c = Use of assigned value by customer

    Name of document: D-00064 Effective date: 2013-06-26 Page 2 of 2

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