21 CFR Subpart J
Products Used In Establishments That Manufacture Blood and Blood Products
June 25, 2020
§
864.9050
Blood bank supplies
§
864.9100
Empty container for the collection and processing of blood and blood components
§
864.9125
Vacuum-assisted blood collection system
§
864.9145
Processing system for frozen blood
§
864.9225
Cell-freezing apparatus and reagents for in vitro diagnostic use
§
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
§
864.9245
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
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