Issue Date: March 14, 1996
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma Establishments

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.

Download the Guidance Document