21 C.F.R. · Food and Drugs
21 C.F.R. § 864.9900

Cord blood processing system and storage container.

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21 C.F.R. § 864.9900 — Cord blood processing system and storage container.

§ 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]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 864.9900
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