§864.9225. Cell-freezing apparatus and reagents for in vitro diagnostic use.
21 C.F.R. § 864.9225
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.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]