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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 C - Cell And Tissue Culture Products |
§ 864.2800 - Animal and human sera.
Latest version.
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§ 864.2800 Animal and human sera.
(a) Identification. Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.
(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]