Product Approval Information
Proper Name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic)
Tradename: Procleix Ultrio Assay
Manufacturer: Gen-Probe Inc, License #1592
Package Insert (PDF - 2.4 MB) - Approved: August 12, 2008
Date: August 12, 2008
Labeling Changes:
- Revision of Intended Use to include an HBV screening claim for individual samples and pooled samples of up to 16 individual donations.
- An Intended Use to include testing of pools of up to 16 donations from donors of Hematopoietic Progenitor Cells (HPCs) or Donor Lymphocytes for Infusion (DLI).
- Inclusion of data for HBV yield cases in normal blood donors.
- Adding a long-term storage claim for cadaveric donor specimens.
- Adding instructions for using the PROCLEIX® Reagent Preparation Incubator (RPI)
- Revision of lot release protocol.
- Other minor labeling text revisions
Date: May 23, 2007
Biologics License Application Supplement: To add the Procleix TIGRIS System for use with the Procleix Ultrio Assay
May 23, 2007 Approval Letter
Date: October 3, 2006
Indication: 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, including donors of whole blood and blood components, source plasma and other living donors. It is also 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.
October 3, 2006 Approval Letter
Date: September 28, 2004
Summary of Basis for Approval (PDF - 604 KB)