21 CFR 866.4800 — Plates And Equipment, Radial Immunodiffusion

Immunology (IM) · Part 866 Subpart E—Immunology Laboratory Equipment and Reagents · § 866.4800

Identification

A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally contains specific antibodies. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.

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 § 866.9.

Product Codes