Regulation Text
(a) Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4) .
(b) Source. The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.
Authority
21 U.S.C. 321,331,351,352,353,355,360,360c,360d,360h,360i,371,372;42 U.S.C. 216,262,263,263a,264.