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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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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 - xxx |
| § 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. |