Blood Grouping Reagents

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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Current Good Manufacturing Practices for Transfusion Services (online CE course)
Blood Grouping Reagents

While transfusion services will not be routinely making their own reagents, it is useful to know where to find the requirements for antisera and reagent red cells. Part 660 Subpart C describes the requirements for reagents used for blood grouping and antibody detection/identification, including:
  • Proper names
  • Colors
  • Potency requirements for antisera
  • Antigen makeup of reagent red cells