eCFR Reference Browser

---

title: "21 CFR §862.1340"

source: "https://www.ecfr.gov/current/title-21/section-862.1340"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "862"

part_subject: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Clinical Chemistry Test Systems"

section_number: "862.1340"

section_subject: "Urinary glucose (nonquantitative) test system."

cfr_reference: "21 CFR 862.1340"

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 urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

(b)Classification. Class II.

§862.1340 - Urinary glucose (nonquantitative) test system.