Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests |
Subpart F - Anti-Human Globulin |
§ 660.50 - Anti-Human Globulin.
Latest version.
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§ 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.
[50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38928, June 15, 2016]