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e-CFR data is current as of July 6, 2020

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9050


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§864.9050   Blood bank supplies.

(a) Identification. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

(b) Classification. Class I (general controls).

[45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]

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