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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 |
§ 864.9285 - Automated cell-washing centrifuge for immuno-hematology.
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§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.
(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
(b) Classification. Class II (performance standards).
[45 FR 60646, Sept. 12, 1980]