Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

Description

These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment.

Scope & Applicability

Regulatory Context

• 21CFR610.40§ 610.40 Test requirements.

  (a) Human blood and blood components. Except as specified in paragraphs (c) and (d) of this section, you, an establishment that collects blood and blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medicalRead full regulation →

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