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    Boditech Tumor Marker Control: Intended Use Instructions For Use

    Uploaded by

    Lidia Narb
    Boditech Tumor marker Control is intended for quality control of tumor marker assay kits. It is supplied in lyophilized form and must be reconstituted with sterile distilled water before use. The control is derived from human materials tested to be non-reactive for HIV, HBV, and HCV, and should be handled as potentially infectious waste. It is stable unopened for the expiration date listed, and opened controls are stable for 1-7 days at 2-8°C depending on the analyte, or up to 14 days frozen at -20 to -80°C except for CEA which has no specified frozen stability.

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    © All Rights Reserved
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    Boditech Tumor Marker Control: Intended Use Instructions For Use

    Uploaded by

    Lidia Narb
    128 views1 page
    Boditech Tumor marker Control is intended for quality control of tumor marker assay kits. It is supplied in lyophilized form and must be reconstituted with sterile distilled water before use. The control is derived from human materials tested to be non-reactive for HIV, HBV, and HCV, and should be handled as potentially infectious waste. It is stable unopened for the expiration date listed, and opened controls are stable for 1-7 days at 2-8°C depending on the analyte, or up to 14 days frozen at -20 to -80°C except for CEA which has no specified frozen stability.

    Original Description:

    protocol de lucru

    Original Title

    CONTROL PSA

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    Boditech Tumor marker Control is intended for quality control of tumor marker assay kits. It is supplied in lyophilized form and must be reconstituted with sterile distilled water before use. The control is derived from human materials tested to be non-reactive for HIV, HBV, and HCV, and should be handled as potentially infectious waste. It is stable unopened for the expiration date listed, and opened controls are stable for 1-7 days at 2-8°C depending on the analyte, or up to 14 days frozen at -20 to -80°C except for CEA which has no specified frozen stability.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    128 views1 page

    Boditech Tumor Marker Control: Intended Use Instructions For Use

    Uploaded by

    Lidia Narb
    Boditech Tumor marker Control is intended for quality control of tumor marker assay kits. It is supplied in lyophilized form and must be reconstituted with sterile distilled water before use. The control is derived from human materials tested to be non-reactive for HIV, HBV, and HCV, and should be handled as potentially infectious waste. It is stable unopened for the expiration date listed, and opened controls are stable for 1-7 days at 2-8°C depending on the analyte, or up to 14 days frozen at -20 to -80°C except for CEA which has no specified frozen stability.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Document No.

    : INS-TMCO-EN
    Revision Date : March 30, 2017 (Rev. 01)

    Boditech Tumor marker Control


    INTENDED USE
    INSTRUCTIONS FOR USE
    Boditech Tumor marker Control is intended for in vitro diagnostic use in the
    Boditech Tumor marker Control is supplied in lyophilized form.
    quality control of Tumor marker Assay Kit. For in vitro diagnostic use only.
    1. Carefully reconstitute each vial of lyophilized with exactly 1 mL of
    sterilized distilled water.
    INTRODUCTION
    2. Close the bottle and allow to stand for 30 minutes before use. Ensure
    The use of Boditech Tumor marker Control may be considered as an objective
    contents are completely dissolved by swirling gently.
    assessment of the precision of Tumor marker Assay Kits and is an integral
    Avoid formation of foam. Do not shake.
    part of Good Laboratory Practices. Boditech Tumor marker Control is
    Dispose of any discarded materials in accordance with the
    provided in lyophilized form.
    requirements of your local waste management
    authorities.
    SAFETY PRECAUTIONS AND WARNINGS
    In the event of damage to the package, contact the
    - For in vitro diagnostic use only. Boditech Med Inc.’s Technical Services.
    - Do not pipette by mouth.
    - Exercise proper precautions that would be normally required for handling MATERIALS SUPPLIED
    laboratory reagents. REF CFPO-94
    - Boditech Tumor marker Control should not be used past the expiration Boditech Tumor marker Control Box (2 vials)
    date. Boditech Tumor marker Control level 1 (1 mL) 1
    - Boditech Tumor marker Control is solely designed to be provided Boditech Tumor marker Control level 2 (1 mL) 1
    instrument-specific calibration curves of Boditech Readers and Tumor Instruction For Use 1
    marker Assay Kits. Control value & Barcode Sheet 1
    - Human source materials from which Boditech Tumor marker Control is
    For Technical Assistance
    derived were tested at a donor level for the Human Immunodeficiency
    Boditech Med Inc.’s Technical Services at
    Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HBsAg) and
    Tel: +82 (33) 243-1400
    Hepatitis C Virus (HCV) antibody, and found to be NON-REACTIVE. FDA-
    E-mail: [email protected]
    approved methods have been used to conduct these tests. However, since
    no method can offer complete assurance as to the absence of infectious
    agents, these human source materials and all patient samples should be Boditech Med Inc.
    handled as though capable of transmitting infectious diseases and should 43, Geodudanji 1-gil, Dongnae-myeon,
    be disposed of as hazardous wastes. Chuncheon-si, Gang-won-do, 24398
    Republic of Korea
    STORAGE AND STABILITY Tel: +82 -33-243-1400 / Fax: +82 -33-243-9373
    - Storage and stability condition of Boditech Tumor marker Control. www.boditech.co.kr
    Unopened
    Analyte Obelis s.a
    Temperature Expiration date
    PSA Bd. Général Wahis 53,
    CEA Until expiration date on 1030 Brussels, BELGIUM
    +2 to +8 °C
    the label. Tel: +(32) -2-732-59-54
    AFP
    Fax: +(32) -2-732-60-03
    E-Mail: [email protected]
    Opened (after reconstitution)
    Analyte
    Temperature Expiration date
    +2 to +8 °C 1 day
    PSA
    -20 to -80 °C 7 days
    +2 to +8 °C 1 day
    CEA*
    -20 to -80 °C -
    +2 to +8 °C 7 days
    AFP
    -20 to -80 °C 14 days
    - CEA*: No frozen stability provided.
    - Close the opened Boditech Hormone Control bottle tightly after use.
    - Once the Boditech Hormone Control was frozen, it should be used ONE
    TIME ONLY for test, because repeated freezing and thawing can result in
    the change of test values.
    - After use, any residual product should NOT BE RETURNED to the original
    vial.
    - Bacterial contamination of reconstituted Boditech Hormone Control will
    cause reductions in the stability of many components. If bacterial
    contamination is suspected, the vial should be discarded and a fresh vial
    needs to be reconstituted.

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