§660.50. Anti-Human Globulin.
21 C.F.R. § 660.50
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).
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.
Notes, amendments, and revision history
Amendments
[50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38928, June 15, 2016]
Authority
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.
Amendments
[50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38928, June 15, 2016]