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  • CTRL CKMB II

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    This certificate of analysis is for lot 53360 of CK-MB control serum II manufactured by Biosystems, S.A. on June 9, 2023 and expiring June 30, 2026. The control material has assigned values for CK of 515 U/L with a range of 438-592 U/L and for CK-MB of 112 U/L with a range of 84-140 U/L. Components are from human origin but have tested negative for HIV, HCV and HBs antigens. This lot meets quality requirements and is approved for sale.

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    This certificate of analysis is for lot 53360 of CK-MB control serum II manufactured by Biosystems, S.A. on June 9, 2023 and expiring June 30, 2026. The control material has assigned values for CK of 515 U/L with a range of 438-592 U/L and for CK-MB of 112 U/L with a range of 84-140 U/L. Components are from human origin but have tested negative for HIV, HCV and HBs antigens. This lot meets quality requirements and is approved for sale.

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    4 views1 page

    CTRL CKMB II

    Uploaded by

    mabag46389
    This certificate of analysis is for lot 53360 of CK-MB control serum II manufactured by Biosystems, S.A. on June 9, 2023 and expiring June 30, 2026. The control material has assigned values for CK of 515 U/L with a range of 438-592 U/L and for CK-MB of 112 U/L with a range of 84-140 U/L. Components are from human origin but have tested negative for HIV, HCV and HBs antigens. This lot meets quality requirements and is approved for sale.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    Biosystems, S.A.

    Costa Brava 30, 08030 Barcelona (Spain)

    CERTIFICATE OF ANALYSIS

    CK-MB CONTROL SERUM II


    COD 18061 LOT 53360 EXP 2026-06-30 MANUF 2023-06-09

    PRODUCT COMPOSITION
    COMPONENT LOT EXP
    II 017XA 2026-06-30

    CONTROL DATA
    CONTROL MATERIAL
    ASSIGNED VALUES
    Component Unit Value Range (min) Range (max)
    CK U/L CK 515 438 592
    CK-MB U/L CK-MB 112 84 140

    Note: Components from human origin have been tested and found to be negative for the presence of antibodies anti-HIV (I and II)
    and anti-HCV as well as for HBs antigen. However the product should be handled cautiously as potentially infectious.

    This lot meets the quality requirements, and it is released for sale

    Approved by: QUALITY CONTROL DEPARTMENT Date: 2023/06/12


    This certificate of analysis is a computer printout and has therefore not been signed by hand.

    Notes

    Form v. 17/01/2022

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