21 C.F.R. § 660.50

Current through October 31, 2024
Section 660.50 - Anti-Human Globulin
(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.

21 C.F.R. §660.50

50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499 , Dec. 12, 2000; 81 FR 38928 , June 15, 2016
81 FR 38928 , 9/13/2016