eCFR Reference Browser

---

title: "21 CFR §864.7500"

source: "https://www.ecfr.gov/current/title-21/section-864.7500"

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: "H"

subpart_subject: "Hematology Kits and Packages"

section_number: "864.7500"

section_subject: "Whole blood hemoglobin assays."

cfr_reference: "21 CFR 864.7500"

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 whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

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

§864.7500 - Whole blood hemoglobin assays.