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Zdrowie i gospodarka · 08/08/2007

FDA Releases Guidance on Hepatitis B Donor Screening Tests

The Food and Drug Administration (FDA) has released a guidance document outlining recommendations for manufacturers of hepatitis B surface antigen (HBsAg) assays used to test whole blood and blood components, including source plasma and source leukocytes, to ensure adequate and appropriate donor screening tests for hepatitis B.

Source: Federal Register — Food and Drug AdministrationOpen original release →