21 C.F.R. § 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).