Jump to content
PathLabTalk

Cliff

The Help
  • Posts

    2,426
  • Joined

  • Last visited

  • Days Won

    104
  • Country

    United States

Files posted by Cliff

  1. Human Plasma Collected by Plasmapheresis

    Human Plasma Collected by Plasmapheresis

    198 downloads

    Submitted

  2. 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

    56 downloads

    Submitted

  3. Standards for Hospital Transfusion Services

    Standards for Hospital Transfusion Services

    122 downloads

    Submitted

  4. Management of Blood Establishment Submissions

    Management of Blood Establishment Submissions

    69 downloads

    Submitted

  5. Blood and blood components

    Blood and blood components

    128 downloads

    Submitted

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

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

    74 downloads

    Submitted

  7. 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)

    65 downloads

    Submitted

  8. 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)

    80 downloads

    Submitted

  9. Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen

    Memorandum to Registered Blood and Plasma Establishments, Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen

    88 downloads

    Submitted

  10. Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    70 downloads

    Submitted

  11. 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

    66 downloads

    Submitted

  12. Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products

    58 downloads

    Submitted

  13. Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase

    Memorandum to All Registered Blood Establishments - Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT)

    49 downloads

    Submitted

  14. 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

    54 downloads

    Submitted

  15. Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma

    Memorandum to All Registered Blood Establishments - Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma

    52 downloads

    Submitted

  16. 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

    66 downloads

    Submitted

  17. 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

    53 downloads

    Submitted

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

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

    64 downloads

    Submitted

  19. 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

    67 downloads

    Submitted

  20. Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/9

    Draft Recommendation for the Quarantine and Disposition of Potentially HBV, HCV or HTLV-1 Contaminated Units from Prior Collections from Repeat Donors with Repeatedly Reactive Screening Tests. (Intended for discussion at the meeting of the BPAC on 12/15/94)

    104 downloads

    Submitted

  21. 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

    93 downloads

    Submitted

  22. 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

    89 downloads

    Submitted

  23. Recipient Serum Samples

    Recipient Serum Samples

    64 downloads

    Submitted

  24. Software Used in Blood Establishments

    Software Used in Blood Establishments

    59 downloads

    Submitted

  25. 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

    82 downloads

    Submitted

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.