21 CFR 862.2485 — Apparatus, Electrophoresis, For Clinical Use

Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2485

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.

Classification Rationale

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.

Product Codes