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 - 1.65 MB) - May 23, 2007

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