CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART J—Products Used In Establishments That Manufacture Blood and Blood Products (§864.9050 to §864.9875) > 864.9050—Blood bank supplies.

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).

Code of Federal Regulations

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