eCFR Reference Browser

---

title: "21 CFR §864.9100"

source: "https://www.ecfr.gov/current/title-21/section-864.9100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "864"

part_subject: "HEMATOLOGY AND PATHOLOGY DEVICES"

subpart_code: "J"

subpart_subject: "Products Used In Establishments That Manufacture Blood and Blood Products"

section_number: "864.9100"

section_subject: "Empty container for the collection and processing of blood and blood components."

cfr_reference: "21 CFR 864.9100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

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