West Nile Virus

FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs - 8/28/2007

FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors - 3/2/2007

Approval Information - WNV Assay (Procleix WNV Assay) - Gen-Probe, Inc - 12/1/2005

FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues - 12/1/2005

FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection''; Withdrawal of Guidance - 6/30/2005 - (PDF, 48 KB)

Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - 6/23/2005

FEDERAL REGISTER: Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay - Final Rule - 10/30/2003 - (PDF, 47 KB)

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus - 10/30/2003 - (PDF, 223 KB)

FDA Statement on Blood Industry's Voluntary Market Withdrawal of Certain Frozen Blood Products to Reduce Risk of West Nile Virus Transmission from Transfusion - 12/12/2002

Workshop on Development of Donor Screening Assays for West Nile Virus - 11/4-5/2002

Transcripts

FDA Issues Final Guidance to Industry on West Nile Virus - 10/25/2002

Information about West Nile Virus and Blood Safety - Updated 10/3/2002

Call for Development of Blood Donor Screening and Supplemental Tests for Infections with West Nile Virus (WNV) - 10/3/2002

West Nile Virus Basics - Centers for Disease Control and Prevention

FDA West Nile Virus Information

 
Updated: August 28, 2007