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 640 - Additional Standards for Human Blood and Blood Products |
Subpart C - Platelets |
§ 640.20 - Platelets.
Latest version.
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§ 640.20 Platelets.
(a) Proper name and definition. The proper name of this product shall be Platelets. The product is defined as platelets collected from one unit of blood and resuspended in an appropriate volume of original plasma, as prescribed in § 640.24(d).
(b) Source. The source material for Platelets is plasma which may be obtained by whole blood collection or by plateletpheresis.
[40 FR 4304, Jan. 29, 1975, as amended at 47 FR 49021, Oct. 29, 1982; 50 FR 4139, Jan. 29, 1985; 72 FR 45887, Aug. 16, 2007]