Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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).

[45 FR 60638, Sept. 12, 1980]
authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 864.9100