U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 864Subpart J - Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
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(a) Identification. Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
