eCFR Reference Browser

---

title: "21 CFR §864.6550"

source: "https://www.ecfr.gov/current/title-21/section-864.6550"

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: "G"

subpart_subject: "Manual Hematology Devices"

section_number: "864.6550"

section_subject: "Occult blood test."

cfr_reference: "21 CFR 864.6550"

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 occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

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

§864.6550 - Occult blood test.