---
kind: "section"
citation: "21 C.F.R. § 864.9900"
title: "21"
number: "864.9900"
heading: "Cord blood processing system and storage container."
url: "https://uscodex.org/cfr/21/864.9900"
---

# §864.9900. Cord blood processing system and storage container.

- (a) **Identification.** A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is a functionally closed processing system that includes containers, other soft goods, and a centrifugation system for cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container.” For the availability of this guidance document, see [§ 864.1(d)](/cfr/21/864.1.md?p=d).

## Notes

### Amendments

[72 FR 4638, Feb. 1, 2007]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[72 FR 4638, Feb. 1, 2007]