OOF · Cryogenic Cord Blood Storage Container
Hematology · 21 CFR 864.9900 · Class 2
Overview
| Product Code | OOF |
|---|---|
| Device Name | Cryogenic Cord Blood Storage Container |
| Regulation | 21 CFR 864.9900 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
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).
Special Controls
*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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
