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Title 21
PART 864 SUBPART j
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Subchapter H
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Part 864
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Subpart j
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
21:8.0.1.1.19.10.1.1
SECTION 864.9050
864.9050 Blood bank supplies.
21:8.0.1.1.19.10.1.2
SECTION 864.9100
864.9100 Empty container for the collection and processing of blood and blood components.
21:8.0.1.1.19.10.1.3
SECTION 864.9125
864.9125 Vacuum-assisted blood collection system.
21:8.0.1.1.19.10.1.4
SECTION 864.9145
864.9145 Processing system for frozen blood.
21:8.0.1.1.19.10.1.5
SECTION 864.9160
864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
21:8.0.1.1.19.10.1.6
SECTION 864.9165
864.9165 Blood establishment computer software and accessories.
21:8.0.1.1.19.10.1.7
SECTION 864.9175
864.9175 Automated blood grouping and antibody test system.
21:8.0.1.1.19.10.1.8
SECTION 864.9185
864.9185 Blood grouping view box.
21:8.0.1.1.19.10.1.9
SECTION 864.9195
864.9195 Blood mixing devices and blood weighing devices.
21:8.0.1.1.19.10.1.10
SECTION 864.9205
864.9205 Blood and plasma warming device.
21:8.0.1.1.19.10.1.11
SECTION 864.9225
864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
21:8.0.1.1.19.10.1.12
SECTION 864.9245
864.9245 Automated blood cell separator.
21:8.0.1.1.19.10.1.13
SECTION 864.9275
864.9275 Blood bank centrifuge for in vitro diagnostic use.
21:8.0.1.1.19.10.1.14
SECTION 864.9285
864.9285 Automated cell-washing centrifuge for immuno-hematology.
21:8.0.1.1.19.10.1.15
SECTION 864.9300
864.9300 Automated Coombs test systems.
21:8.0.1.1.19.10.1.16
SECTION 864.9320
864.9320 Copper sulfate solution for specific gravity determinations.
21:8.0.1.1.19.10.1.17
SECTION 864.9400
864.9400 Stabilized enzyme solution.
21:8.0.1.1.19.10.1.18
SECTION 864.9550
864.9550 Lectins and protectins.
21:8.0.1.1.19.10.1.19
SECTION 864.9575
864.9575 Environmental chamber for storage of platelet concentrate.
21:8.0.1.1.19.10.1.20
SECTION 864.9600
864.9600 Potentiating media for in vitro diagnostic use.
21:8.0.1.1.19.10.1.21
SECTION 864.9650
864.9650 Quality control kit for blood banking reagents.
21:8.0.1.1.19.10.1.22
SECTION 864.9700
864.9700 Blood storage refrigerator and blood storage freezer.
21:8.0.1.1.19.10.1.23
SECTION 864.9750
864.9750 Heat-sealing device.
21:8.0.1.1.19.10.1.24
SECTION 864.9875
864.9875 Transfer set.