§ 864.9225. Cell-freezing apparatus and reagents for in vitro diagnostic use.
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/us/cfr/t21/s§ 864.9225·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]