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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
All Titles
Title 21
Chapter I
Part 864
Subpart J - Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9050 - Blood bank supplies.
§ 864.9100 - Empty container for the collection and processing of blood and blood components.
§ 864.9115 - Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
§ 864.9125 - Vacuum-assisted blood collection system.
§ 864.9145 - Processing system for frozen blood.
§ 864.9160 - Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9165 - Blood establishment computer software and accessories.
§ 864.9175 - Automated blood grouping and antibody test system.
§ 864.9185 - Blood grouping view box.
§ 864.9195 - Blood mixing devices and blood weighing devices.
§ 864.9205 - Blood and plasma warming device.
§ 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 864.9245 - Automated blood cell separator.
§ 864.9275 - Blood bank centrifuge for in vitro diagnostic use.
§ 864.9285 - Automated cell-washing centrifuge for immuno-hematology.
§ 864.9300 - Automated Coombs test systems.
§ 864.9320 - Copper sulfate solution for specific gravity determinations.
§ 864.9400 - Stabilized enzyme solution.
§ 864.9550 - Lectins and protectins.
§ 864.9575 - Environmental chamber for storage of platelet concentrate.
§ 864.9600 - Potentiating media for in vitro diagnostic use.
§ 864.9650 - Quality control kit for blood banking reagents.
§ 864.9700 - Blood storage refrigerator and blood storage freezer.
§ 864.9750 - Heat-sealing device.
§ 864.9875 - Transfer set.
authority:
21 U.S.C. 351
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