21 CFR § 864.9900 - Cord blood processing system and storage container.
---
identifier: "/us/cfr/t21/s864.9900"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9900 - Cord blood processing system and storage container."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9900"
section_name: "Cord blood processing system and storage container."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---
# 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).
[72 FR 4638, Feb. 1, 2007]