eCFR Reference Browser

---

title: "21 CFR §862.3640"

source: "https://www.ecfr.gov/current/title-21/section-862.3640"

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: "D"

subpart_subject: "Clinical Toxicology Test Systems"

section_number: "862.3640"

section_subject: "Morphine test system."

cfr_reference: "21 CFR 862.3640"

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 morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

(b)Classification. Class II.

§862.3640 - Morphine test system.