21 C.F.R. § 864.9050

Current through October 31, 2024
Section 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).

21 C.F.R. §864.9050

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