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Title 21

Displaying title 21, up to date as of 7/17/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 864Hematology and Pathology Devices864.1 – 864.9900
Subpart JProducts Used In Establishments That Manufacture Blood and Blood Products864.9050 – 864.9875
§ 864.9050Blood bank supplies.
§ 864.9100Empty container for the collection and processing of blood and blood components.
§ 864.9115Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions.
§ 864.9125Vacuum-assisted blood collection system.
§ 864.9145Processing system for frozen blood.
§ 864.9160Blood group substances of nonhuman origin for in vitro diagnostic use.
§ 864.9165Blood establishment computer software and accessories.
§ 864.9175Automated blood grouping and antibody test system.
§ 864.9185Blood grouping view box.
§ 864.9195Blood mixing devices and blood weighing devices.
§ 864.9205Blood and plasma warming device.
§ 864.9225Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 864.9245Automated blood cell separator.
§ 864.9275Blood bank centrifuge for in vitro diagnostic use.
§ 864.9285Automated cell-washing centrifuge for immuno-hematology.
§ 864.9300Automated Coombs test systems.
§ 864.9320Copper sulfate solution for specific gravity determinations.
§ 864.9400Stabilized enzyme solution.
§ 864.9550Lectins and protectins.
§ 864.9575Environmental chamber for storage of platelet concentrate.
§ 864.9600Potentiating media for in vitro diagnostic use.
§ 864.9650Quality control kit for blood banking reagents.
§ 864.9700Blood storage refrigerator and blood storage freezer.
§ 864.9750Heat-sealing device.
§ 864.9875Transfer set.