eCFR Reference Browser

---

title: "21 CFR §864.9400"

source: "https://www.ecfr.gov/current/title-21/section-864.9400"

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: "864.9400"

section_subject: "Stabilized enzyme solution."

cfr_reference: "21 CFR 864.9400"

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. A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.

(b)Classification. Class II (performance standards).

§864.9400 - Stabilized enzyme solution.