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Cliff

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Files posted by Cliff

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

    Volume Limits for Automated Collection of Source Plasma

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research The increased number of automated plasma collection devices with  varying capacities for tailoring each collection to the specific  donor has resulted in the existence of multiple Food and Drug  Administration (FDA) approved nomograms which specify, for each  piece of equipment, the maximum volume of plasma to be harvested  from each donor category. Current considerations in determining  the volume of plasma to be collected include gender, height,  weight, hematocrit, and in some centers, the length of time in  process or the number of cycles. Because multiple equipment  types commonly coexist in a location, the potential for error  due to application of an inappropriate nomogram is significantly  increased. The use of various anticoagulant solutions, differing concentrations of the anticoagulant, and a range of anticoagulant to plasma ratios, additionally complicates some schema and  creates additional opportunity for error.

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  2. More information about "Nomenclature for Monoclonal Blood Grouping Reagents"

    Nomenclature for Monoclonal Blood Grouping Reagents

    By Cliff in FDA Memorandum to Blood Establishments

    Nomenclature for Monoclonal Blood Grouping Reagents

    64 downloads

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  3. More information about "Change in Equipment for Processing Blood Donor Samples"

    Change in Equipment for Processing Blood Donor Samples

    By Cliff in FDA Memorandum to Blood Establishments

    Change in Equipment for Processing Blood Donor Samples

    73 downloads

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  4. More information about "Inspections of Military Blood Establishments, Revised Instructions for Command Notification"

    Inspections of Military Blood Establishments, Revised Instructions for Command Notification

    By Cliff in FDA Memorandum to Blood Establishments

    Inspections of Military Blood Establishments, Revised Instructions for Command Notification

    78 downloads

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  5. 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)

    89 downloads

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  6. 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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  7. More information about "Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures"

    Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures

    By Cliff in FDA Memorandum to Blood Establishments

    Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures

    72 downloads

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  8. More information about "Use of Genetic Systems HIV-2 EIA"

    Use of Genetic Systems HIV-2 EIA

    By Cliff in FDA Memorandum to Blood Establishments

    Use of Genetic Systems HIV-2 EIA

    75 downloads

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  9. 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 Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, April 1992. These recommendations supersede those issued on 29 November 1990 which should be archived.
     

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  10. More information about "Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing"

    Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing

    By Cliff in FDA Memorandum to Blood Establishments

    Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing

    71 downloads

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  11. More information about "Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV"

    Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV

    By Cliff in FDA Memorandum to Blood Establishments

    Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV

    77 downloads

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  12. More information about "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)"

    FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

    By Cliff in FDA Memorandum to Blood Establishments

    FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

    65 downloads

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  13. More information about "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)"

    FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

    By Cliff in FDA Blood Guidances

    Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research The Food and Drug Administration (FDA) is now regulating as licensed biologic products test kits that detect total (IgG and IgM) antibody to hepatitis B core antigen (anti-HBc). After 31 March 1991 anti-HBc kits shipped in interstate commerce and labeled for use in screening blood and blood products must bear a U.S. license number.

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  14. More information about "Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)"

    Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)

    By Cliff in FDA Memorandum to Blood Establishments

    Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)

    76 downloads

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  15. More information about "Deficiencies Relating to the Manufacture of Blood and Blood Components"

    Deficiencies Relating to the Manufacture of Blood and Blood Components

    By Cliff in FDA Memorandum to Blood Establishments

    Deficiencies Relating to the Manufacture of Blood and Blood Components

    69 downloads

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  16. More information about "Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components"

    Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components

    By Cliff in FDA Memorandum to Blood Establishments

    Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components

    81 downloads

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  17. More information about "FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica"

    FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica

    By Cliff in FDA Memorandum to Blood Establishments

    FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica

    75 downloads

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  18. More information about "Use of the Recombigen HIV-1 LA Test"

    Use of the Recombigen HIV-1 LA Test

    By Cliff in FDA Memorandum to Blood Establishments

    Use of the Recombigen HIV-1 LA Test

    88 downloads

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  19. More information about "Autologous Blood Collection and Processing Procedures"

    Autologous Blood Collection and Processing Procedures

    By Cliff in FDA Memorandum to Blood Establishments

    Autologous Blood Collection and Processing Procedures

    91 downloads

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  20. More information about "Eight-Hour Hold; Blood and Plasma Inspectors"

    Eight-Hour Hold; Blood and Plasma Inspectors

    By Cliff in FDA Memorandum to Blood Establishments

    Eight-Hour Hold; Blood and Plasma Inspectors

    86 downloads

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  21. More information about "Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen"

    Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen

    By Cliff in FDA Memorandum to Blood Establishments

    Abbott Laboratories' HIVAG-1 test for HIV-1 antigen(s) not recommended for use as a donor screen

    72 downloads

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  22. More information about "Requirements for Computerization of Blood Establishments"

    Requirements for Computerization of Blood Establishments

    By Cliff in FDA Memorandum to Blood Establishments

    Requirements for Computerization of Blood Establishments

    67 downloads

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  23. More information about "Guidance for Autologous Blood and Blood Components"

    Guidance for Autologous Blood and Blood Components

    By Cliff in FDA Memorandum to Blood Establishments

    Guidance for Autologous Blood and Blood Components

    58 downloads

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  24. More information about "Use of the Recombigen HIV-1 Latex Agglutination (LA) Test"

    Use of the Recombigen HIV-1 Latex Agglutination (LA) Test

    By Cliff in FDA Memorandum to Blood Establishments

    Use of the Recombigen HIV-1 Latex Agglutination (LA) Test

    57 downloads

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  25. More information about "Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel"

    Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel

    By Cliff in FDA Memorandum to Blood Establishments

    Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-1) Release Panel

    70 downloads

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