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. [45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]