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Cliff

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Files posted by Cliff

  1. More information about "Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)"

    Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

    By Cliff in FDA Memorandum to Blood Establishments

    Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

    69 downloads

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  2. More information about "Human Plasma Collected by Plasmapheresis"

    Human Plasma Collected by Plasmapheresis

    By Cliff in Health Canada

    Human Plasma Collected by Plasmapheresis

    200 downloads

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  3. More information about "Management of Blood Establishment Submissions"

    Management of Blood Establishment Submissions

    By Cliff in Health Canada

    Management of Blood Establishment Submissions

    71 downloads

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  4. More information about "Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis"

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    By Cliff in FDA Memorandum to Blood Establishments

    Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis

    83 downloads

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  5. More information about "Standards for Hospital Transfusion Services"

    Standards for Hospital Transfusion Services

    By Cliff in Health Canada

    Standards for Hospital Transfusion Services

    125 downloads

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  6. More information about "Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors"

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Licensed Establishments Performing Red Blood Cell Immunizations, Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors

    67 downloads

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  7. More information about "Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis"

    Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

    By Cliff in FDA Memorandum to Blood Establishments

    Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

    68 downloads

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  8. More information about "Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen"

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to All Registered Blood Establishments - Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen

    55 downloads

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  9. More information about "Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software"

    Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software

    By Cliff in FDA Memorandum to Blood Establishments

    Reviewer Guidance for a Premarket Notification Submission For Blood Establishment Computer Software

    75 downloads

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  10. More information about "Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports"

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments - Guidance Regarding Post Donation Information Reports

    92 downloads

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  11. More information about "Memorandum to Registered Blood and Plasma Establishments - Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)"

    Memorandum to Registered Blood and Plasma Establishments - Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood and Plasma Establishments - Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    81 downloads

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  12. More information about "Blood and blood components"

    Blood and blood components

    By Cliff in Health Canada

    Blood and blood components

    131 downloads

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  13. More information about "Deferral of Blood and Plasma Donors Based on Medications"

    Deferral of Blood and Plasma Donors Based on Medications

    By Cliff in FDA Memorandum to Blood Establishments

    Deferral of Blood and Plasma Donors Based on Medications

    79 downloads

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  14. More information about "Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification"

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    By Cliff in FDA Memorandum to Blood Establishments

    Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor Notification

    93 downloads

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  15. More information about "Stakeholder Consultation on the Proposed Regulatory Framework for Blood and Blood Components - Consultation Report"

    Stakeholder Consultation on the Proposed Regulatory Framework for Blood and Blood Components - Consultation Report

    By Cliff in Health Canada

    Stakeholder Consultation on the Proposed Regulatory Framework for Blood and Blood Components - Consultation Report

    58 downloads

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  16. More information about "Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes"

    Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes

    By Cliff in FDA Blood Guidances

    Docket Number: 2002D-0081 Issued by: Center for Biologics Evaluation and Research Blood establishments are required under 21 CFR 610.40(a)(3) and (b) to test donations of human blood and blood components for hepatitis B virus using approved screening tests that are adequate and appropriate for this purpose. One test used to detect the presence of hepatitis B infection is the hepatitis B surface antigen (HBsAg) test.

    0 downloads

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  17. More information about "Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices"

    Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments - Use of an FDA Cleared or Approved Sterile Connecting Device (STCD) in Blood Bank Practices

    98 downloads

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  18. More information about "Volume Limits for Automated Collection of Source Plasma"

    Volume Limits for Automated Collection of Source Plasma

    By Cliff in FDA Memorandum to Blood Establishments

    Volume Limits for Automated Collection of Source Plasma

    73 downloads

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  19. More information about "Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)"

    Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    By Cliff in FDA Memorandum to Blood Establishments

    Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

    85 downloads

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  20. More information about "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products"

    Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products

    By Cliff in FDA Memorandum to Blood Establishments

    Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products

    167 downloads

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  21. More information about "Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk"

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments- Recommendations for Deferral of Donors for Malaria Risk

    90 downloads

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  22. More information about "Software Used in Blood Establishments"

    Software Used in Blood Establishments

    By Cliff in FDA Memorandum to Blood Establishments

    Software Used in Blood Establishments

    60 downloads

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  23. More information about "Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products"

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments, Timeframe for Licensing Irradiated Blood Products

    65 downloads

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  24. More information about "Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems"

    Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood Establishments, Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems

    68 downloads

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  25. More information about "Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors"

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    By Cliff in FDA Memorandum to Blood Establishments

    Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors

    56 downloads

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