miércoles, 9 de diciembre de 2009

Procleix Ultrio Assay: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatiti


Procleix Ultrio Assay
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:

Date: November 4, 2009
Labeling changes to the Package Insert (PI) within the Intended Use and Performance Characteristics section with the revised wording and data to support a supplemental claim for use of the PROCLEIX® ULTRIO Assay 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.

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
Date: October 3, 2006
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.

abrir aquí:
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm092027.htm

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