Proper Name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic) Tradename: Procleix Ultrio Assay Manufacturer: Gen-Probe, Inc, License #1592
Indication:
Intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
The assay is intended for use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
It is also intended for use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.
This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1 and HCV.
November 4, 2009 Approval Letter - Procleix Ultrio Assay PI revised within the Intended Use and Performance Characteristics section with the revised wording to confirm HIV-1 and/or HCV infection in specimens that are repeat reactive in a licensed donor screening test(s) for antibodies to HIV-1 and/or HCV.
October 3, 2006 Approval Letter - Procleix Ultrio Assay Is a qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in plasma and serum specimens from individual human donors.
Proper Name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)
Tradename: Procleix Ultrio Assay
Manufacturer: Gen-Probe, Inc, License #1592
Indication:
Product Information
Supporting Documents
PI revised within the Intended Use and Performance Characteristics section with the revised wording to confirm HIV-1 and/or HCV infection in specimens that are repeat reactive in a licensed donor screening test(s) for antibodies to HIV-1 and/or HCV.
Multiple revisions in PI.
Revisions included to add the Procleix TIGRIS System for use with the Procleix Ultrio Assay.
Is a qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in plasma and serum specimens from individual human donors.
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