View all text of Subpart J [§ 864.9050 - § 864.9875]
§ 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.