Anti-B Blood Grouping Serum
» Anti-B 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 B (or AB). It agglutinates human red cells containing B-antigens, i.e., blood groups B and AB (including subgroups A1B and A2B). It contains a suitable antimicrobial preservative. It meets the requirements of the test for potency, in parallel with, and not less than equivalent to, the U.S. Reference Blood Grouping Serum Anti-B, in agglutinating red blood cells from Group B donors. It meets the requirements of the tests for specificity with Group A1, B, and O cells and confirms the absence of contaminating antibodies reactive with Mg, Wra 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 test for avidity with Group B cells. All fresh or frozen red blood cell suspensions used for these tests are prepared under specified conditions and meet specified criteria. Anti-B Blood Grouping Serum may be artificially colored yellow.
Packaging and storage Preserve at a temperature between 2 and 8.
Expiration date The expiration date for liquid Serum is not later than 1 year and for dried Serum not later than 5 years after date of issue from manufacturer's cold storage (5, 1 year; or 0, 2 years), provided that the expiration date for dried Serum is not later than 1 year after constitution.
Labeling Label it to state that the source material was not reactive for hepatitis B surface antigen, but that no known test method offers assurance that products derived from human blood will not transmit hepatitis. Label it also to state that it is for in vitro diagnostic use. [noteThe labeling is in black lettering imprinted on paper that is white or is colored completely or in part to match the specified yellow color standard.]