eCFR Reference Browser

---

title: "21 CFR §864.5600"

source: "https://www.ecfr.gov/current/title-21/section-864.5600"

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: "F"

subpart_subject: "Automated and Semi-Automated Hematology Devices"

section_number: "864.5600"

section_subject: "Automated hematocrit instrument."

cfr_reference: "21 CFR 864.5600"

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 automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

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

§864.5600 - Automated hematocrit instrument.