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Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.
(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]