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) > 864.9100—Empty container for the collection and processing of blood and blood components.

864.9100—Empty container for the collection and processing of blood and blood components.

(a) Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
(b) Classification. Class II (performance standards).

Code of Federal Regulations

[45 FR 60638, Sept. 12, 1980]