eCFR Reference Browser

---

title: "21 CFR §862.3830"

source: "https://www.ecfr.gov/current/title-21/section-862.3830"

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: "862.3830"

section_subject: "Salicylate test system."

cfr_reference: "21 CFR 862.3830"

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 salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

(b)Classification. Class II.

§862.3830 - Salicylate test system.