Zdrowie i gospodarka · 21.06.2007
Draft Guidance for Industry on Use of the Computer Crossmatch; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: "Computer Crossmatch" (Electronic Based testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)" dated June 2007. The draft guidance document provides recommendations to blood establishments consistent with current good manufacturing practice (CGMP) for the use of a "computer crossmatch," also called an "electronic crossmatch." The computer crossmatch is an alternative to serologic crossmatch and may be used to demonstrate incompatibility between the donor's red blood cell type and the recipient's serum or plasma type.