---
kind: "section"
citation: "21 C.F.R. § 864.9225"
title: "21"
number: "864.9225"
heading: "Cell-freezing apparatus and reagents for in vitro diagnostic use."
url: "https://uscodex.org/cfr/21/864.9225"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 864.9](/cfr/21/864.9.md).

## Notes

### 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]