» Anti-A Blood Grouping Serum conforms to the regulations of the federal Food and Drug Administration concerning biologics (660.20 to 660.29) (see
Biologics 1041). It is a sterile, liquid or dried preparation containing the particular blood group antibodies derived from high-titered blood plasma or serum of human subjects, with or without stimulation by the injection of Blood Group Specific Substance A (or AB). It agglutinates human red cells containing A-antigens, i.e., blood groups A and AB (including subgroups A
1, A
2, A
1B, and A
2B but not necessarily weaker subgroups). It contains a suitable antimicrobial preservative. It meets the requirements to the test for potency, in parallel with, and not less than equivalent to, the U.S. Reference Blood Grouping Serum Anti-A, in agglutinating red blood cells from Group A
1 and Group A
2B donors. It meets the requirements of the tests for specificity with Group A
1, A
2B, B, and O cells and confirms the absence of contaminating antibodies reactive with M
g, Wr
a antigens as well as other antigens having an incidence of 1 percent or greater in the general population (see under
Blood Grouping Serums Anti-D,
Anti-C,
Anti-E,
Anti-c,
Anti-e). It meets the requirements of the tests for avidity with Group A
1 and A
2B cells. All fresh or frozen red blood cell suspensions used for these tests are prepared under specified conditions and meet specified criteria. Anti-A Blood Grouping Serum may be artificially colored blue.