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Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)


FDA, Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,

Document Type:
Draft Guidance for Industry
recommendations for a requalification method under 21 CFR 610.41(b) for deferred donors, based on a determination that their previous reactive test results for antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II) were falsely positive.

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