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21CFR 660.20 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.
Title 21 Part 660 describes the requirements for reagents used for blood grouping and antibody detection/identification, including:
  • Proper names
  • Colors
  • Potency requirements for antisera
  • The antigen makeup of reagent red cells