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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 |
§ 864.9100 - Empty container for the collection and processing of blood and blood components.
Latest version.
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§ 864.9100 Empty container for the collection and processing of blood and blood components.
(a) Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
(b) Classification. Class II (performance standards).
[45 FR 60638, Sept. 12, 1980]