Antibody designation on container label | Definition |
(1) Anti-IgG, -C3d; Polyspecific | Contains anti-IgG and anti-C3d (may contain other anticomplement and anti-immunoglobulin antibodies). |
(2) Anti-IgG | Contains anti-IgG with no anti-complement activity (not necessarily gamma chain specific). |
(3) Anti-IgG; heavy chains | Contains only antibodies reactive against human gamma chains. |
(4) Anti-C3b | Contains only C3b antibodies with no anti-immunoglobulin activity. Note: The antibody produced in response to immunization is usually directed against the antigenic determinant which is located in the C3c subunit; some persons have called this antibody "anti-C3c." In product labeling, this antibody should be designated anti-C3b. |
(5) Anti-C3d | Contains only C3d antibodies with no anti-immunoglobulin activity. |
(6) Anti-C4b | Contains only C4b antibodies with no anti-immunoglobulin activity. |
(7) Anti-C4d | Contains only C4d antibodies with no anti-immunoglobulin activity. |
21 C.F.R. §660.55