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864.9225—Cell-freezing apparatus and reagents for in vitro diagnostic use.
(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.
Code of Federal Regulations
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