§ 864.9900. Cord blood processing system and storage container.
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/us/cfr/t21/s§ 864.9900·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 864.9900
Cord blood processing system and storage container.
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