eCFR Reference Browser

---

title: "21 CFR §862.2485"

source: "https://www.ecfr.gov/current/title-21/section-862.2485"

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: "C"

subpart_subject: "Clinical Laboratory Instruments"

section_number: "862.2485"

section_subject: "Electrophoresis apparatus for clinical use."

cfr_reference: "21 CFR 862.2485"

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 electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

§862.2485 - Electrophoresis apparatus for clinical use.