Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products / § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
§ 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.