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Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen 1.0.0

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About This File

Docket Number: FDA-2022-D-0499
Issued by: Center for Biologics Evaluation and Research

On August 8, 1995, FDA issued a memorandum to all registered blood and plasma establishments entitled, "Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen". This memorandum supplements that memorandum and provides additional recommendations regarding storage of samples for HIV-1 antigen testing as well as clarifications of the previous recommendations regarding specific implementation issues. 


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